Chondrosarcoma

SAN DIEGO, March 17, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the fourth quarter and fiscal year 2024. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. (the "Acquirer") and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the next 12 months. Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company's financial statements are the historical financial statements of the Former Parent. Key Highlights On January 13, 2025, the Company entered into a loan and security agreement (the "Oxford Loan Agreement"), with Oxford Finance LLC ("Oxford"), and received $100.0 million in gross proceeds upon closing. The Oxford Loan Agreement provides for an additional $50.0 million to be funded upon the Company's request and at the lenders' sole discretion. The loan bears interest at (1) 5.61% plus (2) the greater of (i) the 1-Month Term Secured Overnight Financing Right (SOFR), as published by the CME Group or (ii) 4.34%. The Company will make payments of interest on the loan through February 1, 2028, with principal payments beginning on March 1, 2028 through the maturity date of January 1, 2030. Upon the maturity date, the Company will make a final payment of 9.0% of the total repaid principal amount. On January 21, 2025, the Company announced interim efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC). Efficacy was assessed in 10 of the 13 patients who received at least one dose of ozekibart, based on RECIST v1.1 criteria. Results demonstrated one complete response, three partial responses, and six cases of stable disease. Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median progression-free survival (PFS) of 7.85 months. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). Inhibrx has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in the third quarter of 2025. Financial Results Cash and Cash Equivalents. As of December 31, 2024, Inhibrx had cash and cash equivalents of $152.6 million. Subsequent to year-end, the Company entered into the Oxford Loan Agreement and received gross proceeds of $100.0 million. As of February 28, 2025, Inhibrx had cash and cash equivalents of $230.5 million. R&D Expense. Research and development expenses were $33.4 million during the fourth quarter of 2024 as compared to $82.1 million during the fourth quarter of 2023. Research and development expenses decreased during the fourth quarter of 2024 primarily due to a decrease in contract manufacturing expenses, primarily due to the divestiture of INBRX-101, for which we incurred significant expenses during the fourth quarter of 2023 related to large scale drug substance manufacturing services performed by one of the Company's CDMO partners, including the utilization of raw materials; Research and development expenses were $203.7 million during the fiscal year 2024 as compared to $191.6 million during the fiscal year 2023, primarily due to the following factors: an increase in stock option expense following the recognition of $25.9 million upon the acceleration of outstanding options in connection with the closing of the spin-off transaction; an increase in clinical trial expenses primarily due to the ongoing registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma and due to the expansion of the INBRX-106 Phase 1/2 trial and initiation of the Phase 2/3 trial for HNSCC, including expenses for in-house clinical trial support. These increases were offset in part by a decrease in clinical trial expenses as a result of the termination of the INBRX-105 program; and offset in part by a decrease in contract manufacturing expenses in the fourth quarter of 2024 as opposed to the fourth quarter of 2023 following the divestiture of INBRX-101, as discussed above. G&A Expense. General and administrative expenses were $16.7 million during the fourth quarter of 2024, compared to $7.8 million during the fourth quarter of 2023. General and administrative expenses increased during the fourth quarter of 2024 primarily due to legal services incurred in connection with the Company's legal proceedings, which have since concluded, finding the Company not liable for damages. General and administrative expenses were $127.9 million during the fiscal year 2024, compared to $29.4 million during the fiscal year 2023. General and administrative expenses increased during the fiscal year 2024, primarily due to the following factors: one-time expenses of $68.1 million incurred related to the spin-off transaction, which consisted of legal, advisory, and consulting services performed in connection to the transaction; an increase in stock option expense following the recognition of $15.2 million upon the acceleration of outstanding options in connection with the closing of the spin-off transaction; an increase in legal services incurred in connection with the Company's legal proceedings as discussed above; and an increase in pre-commercialization expenses, primarily related to increases in consulting services and scientific publications to support the Company's commercial operations business intelligence strategies related to ozekibart (INBRX-109) and prior to the spin-off transaction, related to INBRX-101, in addition to a focus on patient advocacy and recruitment efforts, offset in part by a decrease in market research efforts following the disposition of INBRX-101. Other Income (Expense). Other income was $2.1 million during the fourth quarter of 2024, compared to other expense of $3.7 million during the fourth quarter of 2023. Following the Company's spin-off transaction in the second quarter of 2024, the Company no longer had any outstanding third-party debt, and therefore did not incur any interest expense during the period. During the fourth quarter of 2024, other income consisted of interest earned on the Company's sweep and money market account balances. Other income was $2.0 billion during the fiscal year 2024 as compared to other expense of $20.5 million during the fiscal year 2023. During the fiscal year 2024, other income consisted of interest earned on the Company's sweep and money market account balances, as noted above, in addition to the gain recorded in connection with the completion of the spin-off transaction. This gain consisted of (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company's outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer. Other expense in the prior year consisted of interest expense related to the Company's third-party debt outstanding in the period. Net Income (Loss). Net loss was $47.9 million during the fourth quarter of 2024, or $3.09 per share, basic and diluted, compared to $93.6 million during the fourth quarter of 2023, or $6.93 per share, basic and diluted. Net income was $1.7 billion during the fiscal year 2024, or earnings per share of $114.01, basic, and $112.62, diluted, compared to a net loss of $241.4 million during the fiscal year 2023, or $20.48 per share, basic and diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding expected data readouts and the timing thereof and the Company's ability to develop therapeutic candidates. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN DIEGO, Jan. 21, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, today announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC). These results were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Annual Cancers Symposium. Efficacy was assessed in 10 of the 13 patients who received at least one dose of ozekibart, based on RECIST v1.1 criteria. Results demonstrated one complete response (CR), three partial responses (PR), and six cases of stable disease (SD). Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median progression-free survival (PFS) of 7.85 months. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). Notably, the patient achieving a CR had undergone three prior lines of therapy, and two PRs occurred in patients who had failed prior FOLFIRI-based treatments. Ozekibart-related treatment-emergent adverse events (TEAEs) were reported in 84.6% of patients, with most being grade 1 or 2 in severity. Grade ≥3 TEAEs were observed in 30.8% of patients. The most common ozekibart-related TEAEs included nausea, increased alanine aminotransferase, diarrhea, and fatigue, with the majority being low-grade. Encouraged by these preliminary results, Inhibrx has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in Q3 2025. "We believe these interim results underscore the potential of ozekibart to provide meaningful clinical benefit for patients with advanced solid tumors, even in heavily pretreated populations. We are particularly encouraged by the durable disease control observed and look forward to further evaluating these findings in our expansion cohort," commented Josep Garcia, Chief Clinical Development Officer at Inhibrx. About Colorectal Adenocarcinoma Colorectal adenocarcinoma is the third most frequent cancer globally and the second leading cause of cancer-related death. According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths. Effective therapies beyond the second-line setting are limited. In the U.S., the five-year relative survival rate in patients with metastatic CRC is 15.7%, underscoring the need for better treatments. About ozekibart (INBRX-109) Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma. In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma, which is currently ongoing and expected to read out in the middle of this year. Additionally, in a Phase 1 trial, Inhibrx is investigating ozekibart in Ewing sarcoma in combination with irinotecan/temozolomide. About Inhibrx Biosciences, Inc. Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. Both programs have key data readouts expected in 2025. For more information, please visit . Forward-Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline any future potential safety and efficacy of its therapeutic candidate, ozekibart; the clinical development of ozekibart, including expected enrollment in the expansion cohort and data readouts and the timing thereof; the potential demand for ozekibart and any presumption that preliminary data will be representative of final data or data in later clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of initial, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; results from preclinical studies or early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of its therapeutic candidates that may limit their development, regulatory approval and/or commercialization; the potential for its programs and prospects to be negatively impacted by developments relating to its competitors, including the results of studies or regulatory determinations relating to its competitors; the timing or likelihood of regulatory filings and approvals and regulatory developments in the U.S. and foreign countries; the successful commercialization of its therapeutic candidates, if approved; an accelerated development or approval pathway may not be available for ozekibart or other therapeutic candidates and any such pathway may not lead to a faster development process; it may not realize the benefits associated with orphan drug designation, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the pricing, coverage and reimbursement of its therapeutic candidates, if approved; its ability to utilize its technology platform to generate and advance additional therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Registration Statement on Form 10, as amended (File No. 001-42031), its Registration Statement on Form S-1, as amended and supplemented from time to time (File No. 333-280127), and its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly Deck, CFO [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

First patient enrolled in the Phase 3 CHONQUER clinical trial in patients with IDH1-mutant conventional chondrosarcoma Phase 3 PyramIDH clinical trial in patients with IDH1-mutant myelodysplastic syndromes has been initiated with sites actively recruiting across the world BOSTON, Jan. 9, 2025 /PRNewswire/ -- Servier today announced updates to two of its Phase 3 programs evaluating TIBSOVO (ivosidenib tablets) in isocitrate dehydrogenase 1 (IDH1)-mutated cancers. The first patient has been enrolled in the CHONQUER study, a pivotal Phase 3 clinical trial evaluating the efficacy and safety of TIBSOVO versus placebo in patients with IDH1-mutated conventional chondrosarcoma. In addition, the Phase 3 PyramIDH clinical trial has been initiated, and sites are actively recruiting across the globe. The PyramIDH study is evaluating TIBSOVO® (ivosidenib tablets) monotherapy and azacitidine monotherapy in the treatment of patients with IDH1-mutated myelodysplastic syndromes (MDS) who have not previously been treated with a hypomethylating agent. "As the leader in IDH-mutated cancers, Servier aspires to provide new treatment options for those impacted by newly diagnosed IDH1-mutated conventional chondrosarcoma and IDH-1 mutated MDS. The advancement of two of our Phase 3 registration enabling studies is an incredibly important milestone for our TIBSOVO clinical development program and underscores our commitment to understanding the application of IDH1m inhibition in a broad range of malignancies to meet the needs of patients," said Susan Pandya, MD, Vice President, Clinical Development and Global Head of Oncology LS/LCM, Servier Pharmaceuticals. "We are deeply grateful to the patients, families and healthcare providers who are participating in this important research." The use of TIBSOVO in patients with IDH1-mutated conventional chondrosarcoma, as well as, patients with IDH1-mutated myelodysplastic syndromes who have not previously been treated with a hypomethylating agent are investigational, and its safety and efficacy in these cases have not been evaluated by any regulatory authority. About the PyramIDH Trial (NCT06465953) PyramIDH is a pivotal Phase 3, multicenter, open label, randomized clinical trial of TIBSOVO (ivosidenib tablets) monotherapy and azacitidine monotherapy in adult patients with myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. The primary endpoint of PyramIDH is complete remission (CR) or partial remission (PR) as per International Working Group (IWG) 2006 criteria at 4 months. Secondary outcome measures include overall response (OR) rate, event-free survival (EFS) and overall survival (OS). About the CHONQUER Trial (NCT06127407) CHONQUER is a pivotal Phase 3, multicenter, double-blind, randomized, placebo-controlled crossover clinical trial of TIBSOVO (ivosidenib tablets) in adult patients with locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase protein, 1 (IDH1) mutation who are untreated or were previously treated with one systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint of CHONQUER is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary outcome measures include endpoints such as PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. The study also will evaluate the impact of TIBSOVO on health-related quality of life (HRQoL) and health economic outcomes. About TIBSOVO® (ivosidenib tablets) TIBSOVO is a precision medicine that targets a specific type of mutation known as isocitrate dehydrogenase 1 (IDH1). TIBSOVO is approved in five indications globally, including approvals in the U.S., European Union, Australia and China. In the U.S., TIBSOVO is approved for the treatment of adults with IDH1-mutant relapsed or refractory AML and in monotherapy or in combination with azacitidine for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy, as monotherapy for the treatment of adult patients with IDH1-mutant relapsed or refractory MDS, and for patients with previously treated IDH1-mutated cholangiocarcinoma. For more information about TIBSOVO in the U.S., please visit . About Myelodysplastic Syndromes Myelodysplastic Syndromes (MDS) are disorders in which progenitor (stem) cells do not mature into healthy blood cells.1 In the U.S., approximately 16,000 new cases of MDS are reported each year.2 Approximately 3.6% of MDS patients have an IDH1 mutation,3 which is considered an early "driver" mutation.4 For MDS patients with an IDH1 mutation, the prognosis has often been associated with worse overall outcomes and in an increased risk of transformation to AML.3 Prior to the approval of TIBSOVO, there were no approved targeted therapies for this molecularly defined subset. About Chondrosarcoma Chondrosarcoma is a group of bone tumors that are made up of cells that make too much cartilage.1 Chondrosarcoma, the second most common sarcoma of the bones following osteosarcoma,5 accounts for 20-30% of all skeletal sarcomas and has an estimated incidence of 1 in 200,000 per year in the U.S.6 Conventional primary chondrosarcoma is the most common variant and makes up 85% of all cases.2 IDH mutations are found in 50-70% of chondrosarcomas.7 Surgery currently remains the mainstay of treatment for conventional chondrosarcoma as both radiation and chemotherapy have been shown to be ineffective.8 About Servier in Oncology Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. Servier is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time. Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio. For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.us. Media Contact Sara Noonan [email protected] TIBSOVO IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS INDICATIONS TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy Relapsed or Refractory AML For the treatment of adult patients with relapsed or refractory AML Relapsed or Refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Differentiation Syndrome in AML and MDS: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome and creatinine increased. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe. QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary. Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia. Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome. ADVERSE REACTIONS In patients with AML, the most common adverse reactions including laboratory abnormalities (≥25%) are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia In patients with MDS, the most common adverse reactions including laboratory abnormalities (≥25%) are creatinine increased, hemoglobin decreased, arthralgia, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, myalgia, phosphate decreased, pruritus, and rash In patients with cholangiocarcinoma, the most common adverse reactions (≥15%) in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (≥10%) in patients with cholangiocarcinoma are hemoglobin decreased, aspartate aminotransferase increased, and bilirubin increased DRUG INTERACTIONS Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation. Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO. Sensitive CYP3A4 substrates: Avoid concomitant use with TIBSOVO. QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation. LACTATION: Advise women not to breastfeed. Please see Full Prescribing Information, including BOXED WARNING for AML and MDS patients 1 Pagliuca S, Gurnari C, Visconte V. Molecular Targeted Therapy in Myelodysplastic Syndromes: New Options for Tailored Treatments. Cancers. 2021;13(4):784. . 2 SEER MDS Incidence Rates. Available at: ; U.S. Census Bureau Population Estimates 2017 National Population Projections Tables: Main Series (census.gov). . Accessed December 5, 2024. 3 Thol F, Weissinger EM, Krauter J, et al. IDH1 mutations in patients with myelodysplastic syndromes are associated with an unfavorable prognosis. Haematologica. 2010;95(10)1668-1674. . Accessed December 5, 2024. 4 DiNardo CD, Jabbour E, Ravandi F, et al. IDH1 and IDH2 mutations in myelodysplastic syndromes and role in disease progression. Leukemia. 2016;30(4):980-4. . Accessed December 5, 2024. 5 Anfinsen KP, Devesa SS, Bray F, et al. Age-Period-Cohort Analysis of Primary Bone Cancer Incidence Rates in the United States (1976–2005) Cancer Epidemiol. Prev. Biomark. 2011;20:1770-1777. . Accessed December 5, 2024. 6 Giuffrida AY, Burgueno JE, Koniaris LG, et al. Chondrosarcoma in the United States (1973 to 2003): An Analysis of 2890 Cases from the SEER Database. JBJS. 2009;91:1063-1072. . Accessed December 5, 2024. 7 Amary MF, Bacsi K, Maggiani F, et al. IDH1 and IDH2 Mutations Are Frequent Events in Central Chondrosarcoma and Central and Periosteal Chondromas but Not in Other Mesenchymal Tumours. J. Pathol. 2011;224:334-343. . Accessed December 5, 2024. 8 Polychronidou G, Karavasilis V, Pollack SM, et al. Novel Therapeutic Approaches in Chondrosarcoma. Future Oncol. 2017;13:637-648. . Accessed December 5, 2024. SOURCE Servier Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED