Ivosidenib

Boston, Massachusetts, August 18, 2026 – Servier today announced that VORANIGO® (vorasidenib) has been nominated for The Galien Foundation’s 2026 Prix Galien International Award in the Best Product for Orphan/Rare Disease category, and TIBSOVO® (ivosidenib) has been nominated in the Best Pharmaceutical Product category. The Prix Galien Award is the world’s highest independent distinction that awards the most critical products introduced in the public market and is regarded as the equivalent of the Nobel Prize in biopharmaceutical research. “We are thrilled to have two medicines from our growing portfolio of first-in-class and best-in-class oncology medicines nominated for the 2026 Prix Galien International Awards,” said Peter Adamson, Global Head of Oncology Clinical Development at Servier. “Servier’s innovative approach to drug development is rooted in our patient-focused and values-driven identity. We are leveraging our deep expertise in rare oncology to advance meaningful therapeutic progress and improve outcomes for people all over the world who are living with rare cancers.” The Prix Galien International Awards are held every two years, recognizing global leaders in pharmaceutical, biotechnology and medical technology innovation. Candidates consist of winners from the Prix Galien National Awards in the preceding two years. VORANIGO previously won the 2025 Prix Galien USA Award, as well as the inaugural 2025 Prix Galien Bridges Award and the 2025 Prix Galien Poland Award in the Orphan/Rare Disease category. TIBSOVO won the 2024 Prix Galien Italy Award in the Best Chemical Synthesis Drug category. The Prix Galien International Awards will be presented to the winners during a ceremony at the American Museum of Natural History in New York City on October 29. Media Contact Marion Breyer: marion.breyer@servier.com About Servier Servier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle. As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to offer targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D. Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion. More information on the Group website: servier.com Follow us on social media: LinkedIn, Facebook, X, Instagram 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 invests close to 20% of revenue from brand-name medicines in R&D each year. 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.com and Servier.us. VORANIGO IMPORTANT SAFETY INFORMATION   What is VORANIGO?  VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.  What are the possible side effects of VORANIGO?  VORANIGO may cause serious side effects, including: Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:   yellowing of your skin or the white part of your eyes (jaundice)  dark tea-colored urine  loss of appetite  pain on the upper right side of your stomach area  feeling very tired or weak  The most common side effects of VORANIGO include:  increased liver enzyme levels in the blood   lack of energy, tiredness  headache  COVID-19  muscle aches or stiffness  diarrhea  nausea  seizure  Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VORANIGO if you have certain side effects.  VORANIGO may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.   These are not all of the possible side effects of VORANIGO.  Before taking VORANIGO, tell your healthcare provider about all of your medical conditions, including if you:  have liver problems  have kidney problems or are on dialysis  smoke tobacco  are pregnant or plan to become pregnant. VORANIGO can harm your unborn baby  Females who are able to become pregnant:   Your healthcare provider will do a pregnancy test before you start treatment with VORANIGO  You should use effective nonhormonal birth control during treatment with VORANIGO and for 3 months after the last dose. VORANIGO may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VORANIGO  Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VORANIGO  Males with female partners who are able to become pregnant:   You should use effective birth control during treatment with VORANIGO and for 3 months after the last dose  Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with VORANIGO Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VORANIGO passes into breast milk. Do not breastfeed during treatment with VORANIGO and for 2 months after the last dose.   Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VORANIGO may affect the way other medicines work, and other medicines may affect how VORANIGO works.  Please click here for full prescribing information.   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 WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. WARNINGS AND PRECAUTIONS Differentiation Syndrome in AML: 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 Disclosures  This release contains general information about the Servier Group and its entities (hereinafter “Servier and its Affiliates”) and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect. Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks.  This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA.  Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction.  The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest.  To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete.  To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice. 

San Diego-based Inhibrx Biosciences, Inc. (Nasdaq: INBX) announced that the US FDA has accepted a Biologics License Application (BLA) for ozekibart (INBRX-109), a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody, filed for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. If approved, ozekibart would be the first systemic therapy approved for this indication and Inhibrx’s first commercial product. The BLA was submitted in April 2026 and carries Fast Track designation, granted in January 2021, along with orphan drug designation awarded in November 2021 for chondrosarcoma. The filing is supported by the ChonDRAgon study, a randomized, blinded, placebo-controlled registrational trial enrolling 206 patients with grade 2 or 3 unresectable or metastatic conventional chondrosarcoma across 67 sites. Topline results reported in October 2025 demonstrated that ozekibart met its primary endpoint, more than doubling median progression-free survival (PFS) to 5.52 months versus 2.66 months for placebo (stratified hazard ratio 0.479; 95% CI: 0.33, 0.68; p\<0.0001), representing a 52% reduction in the risk of disease progression or death. The benefit was consistent across IDH-wild-type and IDH-mutant subgroups. Key secondary endpoints also supported the primary finding: disease control rate was 54% with ozekibart versus 27.5% with placebo, and treatment demonstrated delay in deterioration of pain and physical function. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a mechanism-related risk, occurred predominantly in patients with underlying hepatic impairment during the first treatment cycle; following protocol amendments excluding patients with severe liver impairment and implementing close monitoring, the overall incidence of treatment-related hepatic adverse events was 11.8% in the ozekibart arm versus 4.5% in the placebo arm, with the majority Grade 1 or 2. Ozekibart functions by activating DR5 to induce tumor-biased apoptosis. The tetravalent format is central to its design: DR5 agonism requires receptor clustering to trigger apoptotic signaling, and the multivalent architecture is intended to drive this clustering more potently than conventional bivalent antibodies while exploiting the preferential DR5 expression on malignant cells. Conventional chondrosarcoma, the second most common primary bone malignancy, is largely unresponsive to chemotherapy and radiotherapy, leaving surgical resection as the only established treatment for localized disease. No systemic therapy has previously been approved for the unresectable or metastatic setting. The investigational pipeline is narrow. France-based Servier’s ivosidenib (Tibsovo), an IDH1 inhibitor already approved in acute myeloid leukemia and cholangiocarcinoma, is being evaluated in the Phase III CHONQUER trial (NCT06127407) in IDH1-mutant conventional chondrosarcoma, with primary completion anticipated in February 2028. Eli Lilly’s LY3410738, an IDH1/2 inhibitor, is also in clinical evaluation for this indication. Critically, both ivosidenib and LY3410738 are restricted to IDH-mutant tumors, which represent approximately 50%-70% of cases. Ozekibart, by contrast, demonstrated consistent benefit regardless of IDH mutation status, positioning it as a potentially broader-use agent in this setting. Updated interim data from an expansion cohort in late-line colorectal cancer, reported in April 2026, showed a 20% objective response rate and 87% disease control rate in 45 evaluable heavily pretreated patients as of the April 10, 2026 cutoff, supporting Inhibrx’s plans to explore ozekibart across additional solid tumor indications including Ewing sarcoma. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.