FDA Grants Final Approval to OMCAZIO, a New Capsule Formulation of Cabozantinib

The U.S. Food and Drug Administration (FDA) has granted final approval to OMCAZIO (cabozantinib) capsules, a new formulation of the targeted cancer drug cabozantinib developed by Handa Oncology, according to a Sept. 11, 2026, announcement from Handa Pharmaceuticals. The FDA's decision converts the company's previous tentative approval to final approval and authorizes OMCAZIO for commercialization in the United States.

OMCAZIO is the laurylsulfate salt formulation of cabozantinib and is approved for certain adults with advanced kidney and liver cancers, as well as adults and children 12 and older with certain previously treated neuroendocrine tumors.

One of the key differences with OMCAZIO is that it can be taken with or without food. According to Handa, this removes the strict fasting requirements associated with cabozantinib and gives patients and physicians additional flexibility around treatment.

What cancers is OMCAZIO approved to treat?

OMCAZIO is approved for adults with advanced renal cell carcinoma (RCC), the most common type of kidney cancer. It is also approved for adults with advanced RCC as a first-line treatment in combination with the immunotherapy nivolumab.

The drug is also approved for adults with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. In addition, OMCAZIO can be used in adults and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNETs).

A new formulation of cabozantinib

OMCAZIO is not a new type of cancer treatment. Instead, it is a new capsule formulation of cabozantinib, a kinase inhibitor used to treat several types of cancer.

OMCAZIO was developed under the FDA's 505(b)(2) regulatory pathway and is supplied in three capsule strengths: 34.5 mg, 23 mg and 11.5 mg. The formulation is designed to allow cabozantinib to be taken without regard to food.
For patients, the ability to take OMCAZIO with or without food may provide more flexibility when fitting treatment into their daily routines.

OMCAZIO doses are different from other cabozantinib products

Patients and health care providers should be aware that OMCAZIO is not interchangeable with other cabozantinib products on a milligram-for-milligram basis.

The FDA-approved conversion recommendations specify that a 60-mg once-daily dose of CABOMETYX corresponds to 34.5 mg of OMCAZIO once daily. A 40-mg CABOMETYX dose corresponds to 23 mg of OMCAZIO, while a 20-mg CABOMETYX dose corresponds to 11.5 mg of OMCAZIO.

Because the doses are different, patients should not switch between OMCAZIO and another cabozantinib product on their own. The prescribing and dispensing information should be confirmed to make sure the correct product and dose are being used. The drug carries a boxed warning about the risk of serious adverse reactions or reduced effectiveness resulting from medication errors.

What are the possible side effects of OMCAZIO?

The most common adverse reactions associated with OMCAZIO when used alone include diarrhea, fatigue, palmar-plantar erythrodysesthesia (hand-foot syndrome), decreased appetite, high blood pressure, nausea, vomiting, weight loss and constipation.

When OMCAZIO is used in combination with nivolumab, common adverse reactions include diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, high blood pressure, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, changes in taste, abdominal pain, cough and upper respiratory tract infection.

The prescribing information also includes warnings for serious complications, including bleeding, gastrointestinal perforations and fistulas, blood clots, severe high blood pressure, heart failure, severe diarrhea, liver toxicity, proteinuria, jawbone complications and impaired wound healing.

Patients should discuss potential side effects and any other medications they take with their cancer care team before starting treatment.

What does the FDA approval mean for patients?

The FDA's final approval means OMCAZIO is authorized for commercialization in the United States, moving the drug beyond its previous tentative approval. Handa said it expects to provide additional information about U.S. commercial availability in a subsequent announcement.
The most notable difference for patients is that OMCAZIO can be taken with or without food. This may give patients more flexibility in when they take their medication while still following the dosing instructions provided by their health care team.

OMCAZIO is available in lower milligram-strength capsules that correspond to approved CABOMETYX doses through FDA-approved conversion recommendations. However, because OMCAZIO is not substitutable on a milligram-for-milligram basis with other cabozantinib products, patients should work with their health care team before making any changes to their cabozantinib treatment.The U.S. Food and Drug Administration (FDA) has granted tentative approval to OMCAZIO (cabozantinib) capsules, a new formulation of the targeted cancer drug cabozantinib developed by Handa Oncology, according to a July 31, 2026, announcement from Handa Pharmaceuticals.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.