Intestinal Fistula

NEWTON, Mass.--( BUSINESS WIRE )--Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva ® Pelvic Health System. Byram Healthcare Centers, Inc. (“Byram Healthcare”), EVERSANA, J&B Medical and OneSource Medical Group, LLC, now offer the Leva System, recently named to AARP’s 2023 Medical Breakthroughs , making it easier for physicians, healthcare systems and patients to access safe and effective at-home treatment for incontinence supported by multiple clinical trials and published data. Bladder leaks—called urinary incontinence (UI)—affect 78 million women in the U.S. Accidental bowel leakage, called fecal incontinence (FI), affects 12 million women. While UI and FI are the most prevalent pelvic floor disorders among women, they are vastly undertreated. Shame and embarrassment can keep women from seeking treatment. Left untreated, incontinence can affect women’s mental and physical health, quality of life and relationships. It also leads to higher healthcare costs for both women and insurers. For older women, UI is a leading cause of nursing home placement. Pelvic floor muscle training (PFMT)—or “Kegels”—is globally recommended first-line treatment for UI and FI. However, data show few women perform Kegels consistently or effectively enough to relieve incontinence symptoms. The Leva System combines a small FDA-cleared vaginal motion sensor device and integrated software that allows women to visualize pelvic movement in real-time, offering an effective, non-invasive, medication-free way for them to train and strengthen their pelvic floor. As a prescription device, the Leva System offers multiple ways for clinicians to connect more women with first-line treatment and support them throughout 12 weeks of therapy. “Several recent studies show that women do not regularly receive recommended first-line treatment for incontinence,” said Steven G. Gregg, PhD, executive director of the National Association For Continence (“NAFC”). “While concerning, it’s not surprising. While PFMT is effective, first-line treatment for urinary incontinence, doing Kegels correctly and consistently is hard, and most women don’t have access to specialized physical therapy, which can help. The Leva System makes PFMT accessible by supporting a women’s success as she improves her incontinence symptoms. NAFC applauds all efforts to make access to clinically proven treatment options for incontinence more available for women.” "Women dealing with bladder and bowel leaks are reaching out for support," shared Eileen Maus, CEO of Axena Health. "Pelvic floor muscle training is a globally recommended solution that Leva makes more accessible to women. Through these strategic distributor agreements, we've orchestrated a seamless network, supporting swift access to Leva for patients. We're excited to collaborate with healthcare leaders who share our commitment to offering women non-invasive, drug- and surgery-free options for incontinence treatment." About the Leva ® Pelvic Health System The Leva Pelvic Health System is a prescription medical device available in the United States that offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor device and integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG). In May 2023, Axena Health announced a global study to examine the burdens of incontinence for women in low- and middle-income countries. The findings will guide the development of new treatment options based on the Leva System that are culturally acceptable and available within local healthcare pathways. About Axena Health Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva ® Pelvic Health System , offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com , follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok. Important Indication and Other Information for the Leva® Pelvic Health System The Leva ® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence ( > 3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com .

LOS ANGELES, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) division of the National Institute of Health (NIH). The award provides $400,000 to translate proof-of-principle early research findings of Trethera’s clinical stage first-in-class drug, TRE-515, as an oral therapy for Crohn’s disease. Crohn’s disease is a chronic, relapsing, inflammatory gastrointestinal disorder that can present with diarrhea, fatigue, severe abdominal pain, and weight loss. Almost 1 million Americans suffer from the disease today, with complications including intestinal fistulas, strictures, and colorectal cancer. Up to a third of patients fail to respond to first line therapy drugs and nearly half lose their drug response within 5 years. Steroids can induce remissions but are less effective at maintaining durability and have significant side effects. The disease is primarily driven by autoreactive CD4 T cells of the patient’s own immune system that target antigens in the gut. “A high unmet medical need exists for safe, oral therapies that can be used with first-in-line treatments to help patients maintain disease remission, thereby reducing the need for aggressive broadly immunosuppressive agents. TRE-515 potentially offers a benefit-risk profile that will be ideally suited for patients with moderate to severe Crohn’s disease seeking a well-tolerated agent to diminish relapses,” said Dr. Ken Schultz, principal investigator and Trethera CEO. Figure 1. PET scan images showing presence of target enzyme dCK in a normal mouse (left), and one with Crohn’s disease (right). “We are very pleased to receive this grant that recognizes the strong therapeutic potential that could be provided for the treatment of Crohn’s disease through a first-in-class drug targeting deoxycytidine kinase (dCK),” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator. “The STTR program at NIH plays a vital role in helping companies develop new technologies that serve important U.S. health care needs.” TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway. A common characteristic of pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division. In contrast, dCK activity is not required in most healthy adult human cells. Mediated by the rate-limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the aberrant activated lymphocytes found in Crohn’s disease to divide, suggesting dCK as a potential therapeutic target with expected enhanced safety. Sources: NEnglJMed.2020 Dec 31;383(27); Lancet.2017 Apr 29;389; Gastro.2010 Apr138; AmJGastro.2009 Mar;104 About Trethera Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera's innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients. For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com. Note on Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as "may," "might," "will," "will likely result," "would," "should," "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "continue," "target" or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The content of this press release is solely the views of its authors and does not represent the official views of the NIH. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a36a116d-4f72-40ab-bf03-916d2732d57b

Approval is based on data from a pivotal clinical trial showing that treatment with LONSURF plus bevacizumab resulted in statistically significant and clinically meaningful improvements in overall survival in patients with previously treated mCRC compared to LONSURF as a single agent PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Continue Reading Taiho Pharmaceutical "The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population," said Marwan Fakih, MD, Professor, Medical Oncology and Therapeutics Research, City of Hope, Duarte, Calif., and lead U.S. investigator for the pivotal Phase 3 SUNLIGHT trial that evaluated this combination. "Notably, the use of LONSURF plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination." The results from the Phase 3 SUNLIGHT trial, which were published in the New England Journal of Medicine in May 2023, demonstrated that the combination of LONSURF plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to LONSURF alone.1 This was the first Phase 3 study against an active control in third-line mCRC that demonstrated statistically significant efficacy and safety. Key results include: Median OS was 10.8 months in the LONSURF plus bevacizumab arm versus 7.5 months in the LONSURF arm (hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.49-0.77, p<0.001).1 This improvement in OS represented a 39% reduction in the risk of death in patients with mCRC.1 The median PFS was 5.6 months in the LONSURF plus bevacizumab arm versus 2.4 months in the LONSURF arm (HR: 0.44, 95% CI: 0.36-0.54, p<0.001), indicating a 56% relative risk reduction of disease progression.1 Results were consistent across subgroups regardless of age, sex, location of primary disease, number of metastatic sites, KRAS mutation status, and prior bevacizumab treatment.1 Median time to worsening of the ECOG performance status score from 0 or 1 to 2 or more was 9.3 months (95% CI: 8.3-10.6) in the LONSURF plus bevacizumab arm versus 6.3 months (95% CI: 5.6-7.2) in the LONSURF arm (HR: 0.54, 95% CI: 0.43-0.67).1 The OS and PFS benefits of LONSURF plus bevacizumab were associated with maintenance of quality of life from baseline to cycle 6 and no clinically relevant changes in mean scores were observed in any subdomains for EORTC QLQ-C30 and EuroQol EQ-5D-5L health-related quality of life questionnaires.2 The combination of LONSURF plus bevacizumab had a manageable safety profile as was expected based on the known profile of each agent.1 The most frequent severe treatment emergent adverse events for LONSURF plus bevacizumab versus LONSURF alone were neutropenia (43.1% vs 32.1%) and anemia (6.1% vs 11.0%), respectively.1 "The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients3 with colorectal cancer in the U.S. are diagnosed after the cancer has metastasized," said Timothy Whitten, President and Chief Executive Officer, Taiho Oncology, Inc. "The FDA approval of LONSURF in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families." In 2023, the National Comprehensive Cancer Network® (NCCN®) Drugs and Biologics Compendium (NCCN Compendium®) for Colon Cancer and Rectal Cancer was updated to include a Category 2A recommendation for trifluridine/tipiracil as subsequent therapy, either single agent or in combination with bevacizumab (preferred) (per NCCN®, an FDA-approved biosimilar is an appropriate substitute for bevacizumab),a as treatment options for patients who have progressed through all available regimens besides regorafenib or trifluridine/tipiracil with or without bevacizumab.3,4 "From Taiho Pharmaceutical's initial discovery of LONSURF to this latest regulatory milestone, we are appreciative of the investigators and patients who helped to contribute to our growing body of knowledge of this important therapeutic through their participation in our clinical development programs," said Fabio Benedetti, MD, Global Chief Medical Officer for Oncology, Taiho Pharmaceutical Co., Ltd. "And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may be candidates for treatment with LONSURF in combination with bevacizumab." On July 31, 2023, Servier, which conducted the SUNLIGHT trial with Taiho Oncology, received approval from the European Commission for LONSURF in combination with bevacizumab for the treatment of adult patients with mCRC who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway. About the SUNLIGHT Trial1 SUNLIGHT is a multinational, randomized, active-controlled, open-label, two-arm Phase 3 clinical trial to investigate the efficacy and safety of LONSURF plus bevacizumab versus LONSURF alone, in patients with metastatic colorectal cancer following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive LONSURF in combination with bevacizumab or LONSURF monotherapy. The primary objective was to assess LONSURF plus bevacizumab versus LONSURF alone in terms of OS (primary endpoint). Key secondary endpoints were PFS, overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of LONSURF used in combination with bevacizumab in comparison with LONSURF monotherapy. For more information on SUNLIGHT, please visit: . About Colorectal Cancer Colorectal cancer is the third most commonly diagnosed cancer in the U.S.5 In 2023, there will be an estimated 153,020 new cases and 52,550 deaths in the U.S.6 Approximately 22% of U.S. patients are diagnosed after their cancer has metastasized.3 The relative five-year survival rate for patients with metastatic colorectal cancer is 14%.3 About LONSURF LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation. INDICATIONS LONSURF is indicated as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild-type, an anti‑EGFR therapy. LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Severe Myelosuppression: In the 1114 patients who received LONSURF as a single agent, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (38%), anemia (17%), thrombocytopenia (4%) and febrile neutropenia (3%). Three patients (0.3%) died due to neutropenic infection/sepsis; four other patients (0.5%) died due to septic shock. A total of 14% of patients received granulocyte-colony stimulating factors. In the 246 patients who received LONSURF in combination with bevacizumab, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (52%), anemia (5%), thrombocytopenia (4%) and febrile neutropenia (0.4%). One patient (0.4%) died due to abdominal sepsis and two other patients (0.8%) died due to septic shock. A total of 29% of patients received granulocyte-colony stimulating factors. Obtain complete blood counts prior to and on Day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for severe myelosuppression and resume at the next lower dosage. Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose. USE IN SPECIFIC POPULATIONS Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose. Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose. Geriatric Use: Patients 65 years of age or older who received LONSURF as a single agent had a higher incidence of the following hematologic laboratory abnormalities compared to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (20% vs 14%), and Grade 3 or 4 thrombocytopenia (6% vs 3%). Patients 65 years of age or older who received LONSURF in combination with bevacizumab had a higher incidence of the following hematologic laboratory abnormalities compared to patients younger than 65 years: Grade 3 or 4 neutropenia (60% vs 46%) and Grade 3 or 4 thrombocytopenia (5% vs 4%). Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m2. Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin > 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin > 3 times ULN and any AST) were not studied. No adjustment to the starting dosage of LONSURF is recommended for patients with mild hepatic impairment. ADVERSE REACTIONS Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions (≥2%) were intestinal obstruction (2.8%), and COVID-19 (2%). Fatal adverse reactions occurred in 1.2% of patients who received LONSURF in combination with bevacizumab, including rectal fistula (0.4%), bowel perforation (0.4%) and atrial fibrillation (0.4%). The most common adverse reactions or laboratory abnormalities (≥10% in incidence) in patients treated with single-agent LONSURF at a rate that exceeds the rate in patients receiving placebo were anemia (77% vs 33%), neutropenia (67% vs 0.8%), asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), thrombocytopenia (42% vs 8%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 19%), and pyrexia (19% vs 14%). The most common adverse reactions or laboratory abnormalities (≥20% in incidence) in patients treated with LONSURF in combination with bevacizumab vs LONSURF alone were neutropenia (80% vs 68%), anemia (68% vs 73%), thrombocytopenia (54% vs 29%), fatigue (45% vs 37%), nausea (37% vs 27%), increased aspartate aminotransferase (34% vs 28%), increased alanine aminotransferase (33% vs 23%), increased alkaline phosphate (31% vs 36%), decreased sodium (25% vs 20%), diarrhea (21% vs 19%), abdominal pain (20% vs 18%), and decreased appetite (20% vs 15%). Please see accompanying full Prescribing Information. About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development of orally administered anti-cancer agents and markets these medicines for a range of tumor types in the U.S. Taiho Oncology's growing pipeline of antimetabolic and selectively targeted anti-cancer agents is led by a world-class clinical development organization. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Zug, Switzerland and Oakville, Ontario, Canada. For more information, visit . About Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (), is an R&D-driven specialty pharma with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, and consumer healthcare products. Our corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." For more information about Taiho Pharmaceutical, please visit: . LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd. Taiho Oncology Media Contact: Judy Kay Moore Taiho Oncology, Inc. 574-526-2369 [email protected] Taiho Pharmaceutical Media Contact: Junko Onishi Taiho Pharmaceutical Co., Ltd. +81-3293-2878 [email protected] LON-PM-US-1711 08/23 a Regorafenib or trifluridine + tipiracil with or without bevacizumab are treatment options for patients who have progressed through all available regimens. 1 Prager GW, Taieb J, Fakih M, et al. Trifluridine–tipiracil and bevacizumab in refractory metastatic colorectal cancer. New England Journal of Medicine. 2023;388(18):1657-1667. Last accessed: July 2023. 2 Prager G, Taieb J, Fakih M, et al. O-9 health-related quality of life associated with trifluridine/tipiracil in combination with bevacizumab in refractory metastatic colorectal cancer: An analysis of the phase 3 sunlight trial. Annals of Oncology. 2023;34. Last accessed July 2023. . 3 Wang J, Li S, Liu Y, Zhang C, Li H, Lai B. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population-based analysis. Cancer Med. 2020;9(1):361-373. Last accessed: July 2023. . 4 National Comprehensive Cancer Network. National Comprehensive Cancer Network® Drugs and Biologics Compendium (NCCN Compendium®) for Colon Cancer (Version 2.2023-April 25, 2023) and Rectal Cancer (Version 3.2023-May 26, 2023). Last accessed July 2023. . 5 Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. American Cancer Society CA: A Cancer Journal for Clinicians. 2023;73(1):17-48. Last accessed: July 2023. . 6 National Cancer Institute Surveillance Epidemiology and End Results Program. Cancer Stat Facts: Colorectal Cancer. SEER. Last accessed July 13, 2023. . SOURCE Taiho Oncology, Inc.