FDA Grants Final Approval to Cabozantinib Capsule Formulation

The FDA has granted final approval to a laurylsulfate salt formulation of cabozantinib (Omcazio), converting the product’s prior tentative approval and authorizing commercialization in the United States.¹

The new formulation is approved for administration without regard to food, removing the strict fasting requirements associated with the original cabozantinib tablet formulation (Cabometyx). Per the approved prescribing information, Omcazio is indicated for adult patients with advanced renal cell carcinoma (RCC); adult patients with advanced RCC as first-line treatment in combination with nivolumab (Opdivo); adult patients with hepatocellular carcinoma (HCC) previously treated with sorafenib (Nexavar); and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced, or metastatic, well-differentiated extrapancreatic neuroendocrine tumors (epNET).

“Final approval from the FDA is a landmark milestone for Handa and reflects our patient-centered approach to pharmaceutical innovation,” said Bill Liu, PhD, chairman and CEO of Handa Pharma, the manufacturer, in the news release. “Omcazio is a differentiated cabozantinib option that can be taken with or without food, giving physicians and patients added flexibility in treatment.”

Regulatory Background

Final approval follows the FDA’s tentative approval of the capsule formulation in July 2026.³ Omcazio was developed under the FDA’s 505(b)(2) regulatory pathway, which allows an applicant to rely in part on safety and efficacy data from a previously approved product.¹ The capsule formulation uses an alternate salt of cabozantinib engineered for improved absorption; in bioavailability and bioequivalence studies submitted to the FDA, the capsules were shown to be bioequivalent to the tablet formulation at a lower dose and to have no clinically significant food effect. The labeled indications are based on efficacy data determined with the original tablet formulation rather than new trials of the capsule.

The RCC indication is based on the phase 3 METEOR trial (NCT01865747), in which cabozantinib improved overall survival (OS) compared with everolimus in patients previously treated with a VEGFR tyrosine kinase inhibitor.³ The first-line RCC combination with nivolumab is based on the phase 3 CheckMate 9ER trial (NCT03141177), which showed longer progression-free survival (PFS) and OS compared with sunitinib (Sutent).⁴ The HCC indication is supported by the phase 3 CELESTIAL trial (NCT01908426), in which cabozantinib improved OS compared with placebo in patients previously treated with sorafenib.⁵ The epNET indication is based on the phase 3 CABINET trial (NCT03375320), which found that cabozantinib significantly extended PFS compared with placebo in patients with previously treated epNET and pancreatic NETs.⁶

Dosing and Medication-Error Information

Omcazio is supplied in 34.5-mg, 23-mg, and 11.5-mg capsule strengths and carries a boxed warning describing the risk of serious adverse reactions or reduced effectiveness from medication errors, because the capsule and tablet formulations are not substitutable on a milligram-for-milligram basis. The approved labeling includes a dose-conversion table: a Cabometyx tablet dose of 60 mg once daily corresponds to an Omcazio capsule dose of 34.5 mg once daily; 40 mg once daily corresponds to 23 mg once daily; and 20 mg once daily corresponds to 11.5 mg once daily.

Safety Findings

The most common adverse reactions (occurring in 20% or more of patients) with Omcazio monotherapy are diarrhea, fatigue, palmar-plantar erythrodysesthesia, decreased appetite, hypertension, nausea, vomiting, decreased weight, and constipation. Additional warnings include hemorrhage, gastrointestinal perforation and fistula, thromboembolic events, hypertensive crisis, cardiac failure, osteonecrosis of the jaw, impaired wound healing, reversible posterior leukoencephalopathy syndrome, thyroid dysfunction, and embryo-fetal toxicity; when combined with nivolumab, hepatotoxicity and adrenal insufficiency require additional monitoring.

Handa stated it expects to provide additional information regarding US commercial availability of Omcazio in a subsequent announcement.

REFERENCES

1. Handa Oncology Receives FDA Final Approval for OMCAZIO™ (cabozantinib) Capsules. News release. Handa Pharmaceuticals, Inc. September 11, 2026. Accessed September 11, 2026. https://tinyurl.com/mpnv44c9

2. Handa Oncology Receives FDA Tentative Approval for OMCAZIO (cabozantinib) Capsules. News release. Handa Oncology. July 31, 2026. Accessed September 11, 2026. https://tinyurl.com/59p5dbvx

3. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3.

4. Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2021 Mar 4;384(9):829-841. doi: 10.1056/NEJMoa2026982.

5. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.

6. Chan JA, Geyer S, Zemla T, et al. Phase 3 trial of cabozantinib to treat advanced neuroendocrine tumors. N Engl J Med. 2025 Feb 13;392(7):653-665. doi: 10.1056/NEJMoa2403991.