Nivolumab

A novel 505(b)(2) alternate-salt formulation of cabozantinib designed to improve absorption, with no clinically significant food effect TAIPEI, TW / ACCESS Newswire / July 31, 2026 / Handa Pharmaceuticals, Inc. ("Handa") (TSE:6620) announced that the U.S. Food and Drug Administration ("FDA") has granted tentative approval to OMCAZIO TM (cabozantinib) capsules, a novel alternate-salt formulation of cabozantinib developed by Handa's U.S. subsidiary, Handa Oncology, LLC (the "Company"). OMCAZIO (cabozantinib) capsules are indicated for the treatment of: adult patients with advanced renal cell carcinoma (RCC); adult patients with advanced RCC, in combination with nivolumab, as a first-line treatment; adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET). OMCAZIO was developed under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In bioavailability/bioequivalence studies, OMCAZIO was shown to be bioequivalent to CABOMETYX ®1 at a lower dose, and demonstrated no clinically significant food effect, and improved absorption of cabozantinib. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Because OMCAZIO is bioequivalent to CABOMETYX at a lower dose, the OMCAZIO label includes the following recommendations for converting patients between the two products: CABOMETYX tablets dosage OMCAZIO capsules dosage 60 mg once daily 34.5 mg once daily 40 mg once daily 23 mg once daily 20 mg once daily 11.5 mg once daily "Tentative approval marks an important regulatory milestone for Handa. We developed OMCAZIO with the goal of providing an alternative oral cabozantinib formulation that may offer greater flexibility for patients and healthcare providers." said Bill Liu, Chairman and CEO of Handa. "We are continuing our commercial readiness activities and look forward to making OMCAZIO available to patients following FDA final approval." A tentative approval indicates that FDA has determined that an application meets the agency's standards for safety, effectiveness and manufacturing quality. Cabozantinib is one of the commonly used oral targeted therapies in oncology. According to Exelixis, Inc., U.S. net product revenues for CABOMETYX were approximately $2.11 billion in 2025. 2 Important Safety Information Boxed Warning: WARNING: RISK OF SERIOUS ADVERSE REACTIONS OR REDUCED EFFECTIVENESS DUE TO MEDICATION ERRORS OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Inappropriate substitution or incorrect conversion of OMCAZIO capsules for another cabozantinib product can increase the risk of serious adverse reactions. Confirm that the intended cabozantinib product at the intended dosage and strength is being prescribed and dispensed. WARNINGS AND PRECAUTIONS Risk of Serious Adverse Reactions or Reduced Effectiveness Due to Medication Errors: Cabozantinib is available in multiple dosage forms and strengths. OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Confirm that the intended cabozantinib product is being prescribed and dispensed. Hemorrhage: Do not administer OMCAZIO if recent history of hemorrhage. Perforations and Fistulas: Monitor for symptoms. Discontinue OMCAZIO for Grade 4 events. Thromboembolic Events: Discontinue OMCAZIO for myocardial infarction or serious venous or arterial thromboembolic events. Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Interrupt OMCAZIO for hypertension not adequately controlled with anti-hypertensive therapy. Discontinue OMCAZIO for hypertensive crisis or severe hypertension that cannot be controlled. Cardiac Failure: Monitor for signs and symptoms of cardiac failure throughout treatment. Diarrhea: May be severe. Interrupt OMCAZIO until diarrhea resolves or improve to ≤Grade 1, then resume at reduced dose. Recommend standard antidiarrheal treatments. Palmar-Plantar Erythrodysesthesia (PPE): Interrupt OMCAZIO treatment until PPE resolves or improves to Grade 1. Hepatotoxicity: When used with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with OMCAZIO alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider withholding OMCAZIO and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life- threatening hepatotoxicity. Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency may occur. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold OMCAZIO and/or nivolumab depending on severity. Proteinuria: Monitor urine protein. Interrupt OMCAZIO until proteinuria resolves to ≤Grade 1, resume OMCAZIO at a reduced dose. Discontinue for nephrotic syndrome. Osteonecrosis of the jaw (ONJ): Withhold OMCAZIO for at least 3 weeks prior to invasive dental procedures and for development of ONJ. Impaired Wound Healing: Withhold OMCAZIO for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of OMCAZIO after resolution of wound healing complications has not been established. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue OMCAZIO. Thyroid Dysfunction: Monitor thyroid function before and during treatment with OMCAZIO. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Adverse Reactions The most common adverse reactions (≥20%) include: OMCAZIO as a single agent - diarrhea, fatigue, palmar‑plantar erythrodysesthesia (PPE), decreased appetite, hypertension, nausea, vomiting, decreased weight, and constipation. OMCAZIO in combination with nivolumab - diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection. Drug Interactions Strong CYP3A inhibitors: Reduce the OMCAZIO dosage if coadministration cannot be avoided. Strong or moderate CYP3A inducers: Increase the OMCAZIO dosage if coadministration cannot be avoided. Contraindication: None. Use in Specific Populations Lactation: Advise not to breastfeed. Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing OMCAZIO if abnormalities occur. About OMCAZIO OMCAZIO is a novel alternate-salt capsule formulation of cabozantinib, a tyrosine kinase inhibitor. The formulation is engineered to improve absorption and can be administered with or without food. OMCAZIO has received tentative approval from the FDA and is not yet available for commercial distribution in the United States. About Handa Pharmaceuticals, Inc. Handa is a specialty pharmaceutical company that focuses on developing high-quality medications that address significant unmet medical needs in oncology and neurology. Handa's leadership has a proven track record of building effective teams, high quality product portfolios and successful pharmaceutical businesses. For more information, please visit Forward-Looking Statements This document and the related information released concurrently contain forward-looking statements. Except for statements of historical fact, all statements regarding the future business operations, possible events, and outlook of Handa - including, but not limited to, forecasts, targets, estimates, and operational plans - are forward-looking statements. These statements are subject to various factors and uncertainties that could cause actual results to differ materially from those expressed or implied. Such factors include, but are not limited to, price fluctuations, actual demand, exchange rate movements, market share, competitive conditions, changes in the legal, financial, and regulatory environment, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond Handa's control. These forward-looking statements are based on current forecasts and assessments, and Handa assumes no obligation to update them. Contact: Email: info@handapharma.com Phone: +1 (510) 354-2888 CABOMETYX ® is a registered trademark of Exelixis, Inc. Handa is not affiliated with Exelixis, Inc. References 1 CABOMETYX ® (cabozantinib) tablets, prescribing information 2 Exelixis, Inc. annual report / Form 10-K SOURCE: Handa Pharma, Inc. View the original press release on ACCESS Newswire