FDA Grants Final Approval to Cabozantinib Capsules Across Multiple Solid Tumor Indications

The U.S. Food and Drug Administration (FDA) has granted final approval to cabozantinib (Omcazio) capsules, converting a prior tentative approval into full commercial authorization in the United States. Developed by Handa Oncology, LLC, a subsidiary of Handa Pharmaceuticals, Inc., cabozantinib is a laurylsulfate salt formulation approved through the 505(b)(2) regulatory pathway.

A central clinical distinction of cabozantinib is its administration flexibility. Approved for administration with or without food, cabozantinib removes strict dietary fasting requirements associated with standard oral cabozantinib formulations, offering scheduling convenience for patients undergoing targeted therapy.

Approved Clinical Indications

According to the approved prescribing information, cabozantinib is indicated across four distinct solid tumor oncology patient populations:

• Advanced Renal Cell Carcinoma (RCC): Monotherapy for adult patients with advanced RCC.
• First-Line Advanced RCC Combination Therapy: First-line treatment for adult patients with advanced RCC in combination with nivolumab.
• Hepatocellular Carcinoma (HCC): Treatment for adult patients with HCC who have received prior therapy with sorafenib.
• Extra-Pancreatic Neuroendocrine Tumors (epNET): Treatment for adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET.

Dosing Conversion Ratios and Boxed Warning

Cabozantinib is supplied in 34.5 mg, 23 mg, and 11.5 mg capsule strengths. The prescribing label contains a Boxed Warning emphasizing the risk of serious adverse reactions or reduced therapeutic effectiveness resulting from medication errors.

Cabozantinib is not substitutable on a milligram-to-milligram basis with other cabozantinib products, such as Cabometyx tablets. Inappropriate substitution or incorrect dose conversion can lead to severe toxicity or subtherapeutic exposure.

Key Nursing Takeaways: Dosing and Administration Safety

• Verify Drug Formulation and Strength: Confirm that prescriptions explicitly state cabozantinib capsules at the intended dosage and strength rather than tablet formulations prior to dispensing or administration.
• Educate on Non-Equivalent Strengths: Explain to patients and clinical care teams that cabozantinib uses lower milligram doses (34.5 mg, 23 mg, and 11.5 mg) to achieve bioexposure equivalent to standard tablet doses (60 mg, 40 mg, and 20 mg).
• Reinforce Dietary Flexibility: Instruct patients that cabozantinib capsules may be taken with or without meals, eliminating fasting instructions required for older cabozantinib preparations.
• Screen for CYP3A4 Interactions: Review concomitant medications for strong CYP3A4 inhibitors (requiring cabozantinib dose reductions) and strong or moderate CYP3A4 inducers (requiring dose increases).

Safety Profile, Warnings, and Adverse Reactions

The boxed safety profile and warnings for cabozantinib encompass multiple organ systems. Cabozantinib must not be administered to patients with a recent history of hemorrhage. Clinical teams must monitor for gastrointestinal perforations and fistulas, permanently discontinuing therapy for Grade 4 events. Cabozantinib must be discontinued for myocardial infarction or serious venous or arterial thromboembolic events. Cardiac failure requires monitoring throughout treatment. Regular blood pressure monitoring is mandatory; cabozantinib should be held for uncontrolled hypertension and permanently discontinued for hypertensive crisis. Severe diarrhea requires treatment interruption until symptoms resolve to Grade 1 or lower, followed by dose reduction. Palmar-plantar erythrodysesthesia (PPE) warrants holding treatment until Grade 1 resolution.

Surgical and dental risks necessitate specific dosing holds. Cabozantinib must be withheld for at least 3 weeks prior to elective surgery and held at least 2 weeks following major surgery until wound healing is complete. Dosing must be withheld for at least 3 weeks prior to invasive dental procedures due to osteonecrosis of the jaw (ONJ) risks. Coadministration with nivolumab increases the incidence of Grade 3 and 4 ALT and AST elevations, as well as primary or secondary adrenal insufficiency.

Additional precautions include monitoring for proteinuria (discontinue for nephrotic syndrome), thyroid dysfunction, reversible posterior leukoencephalopathy syndrome (RPLS; discontinue), and embryo-fetal toxicity.

Single-agent cabozantinib adverse reactions occurring in 20% or more of patients include diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, decreased weight, and constipation. Common combination reactions (≥20%) with nivolumab include diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

Key Nursing Takeaways

• Perform Baseline and Serial Assessments: Obtain baseline blood pressure, liver enzymes, urine protein, and thyroid function tests, repeating these laboratory evaluations at regular intervals throughout therapy.
• Coordinate Perioperative and Dental Holds: Ensure cabozantinib is withheld at least 3 weeks before elective surgeries or invasive dental work, resuming post-operatively only after complete wound healing.
• Manage Combination Immunotherapy Risks: Assess patients receiving cabozantinib with nivolumab for severe hepatotoxicity and signs of adrenal insufficiency, preparing to initiate corticosteroids or hormone replacement therapy.
• Provide Counseling for Special Populations: Advise females of reproductive potential regarding embryo-fetal risks and mandatory contraception; instruct lactating mothers to avoid breastfeeding. Monitor open growth plates in adolescent pediatric patients aged 12 and older.

Reference

Handa Pharmaceuticals, Inc. Handa Oncology receives FDA final approval for OMCAZIO™ (cabozantinib) capsules. BioSpace. Published September 11, 2026. Accessed September 11, 2026. https://www.biospace.com/press-releases/handa-oncology-receives-fda-final-approval-for-omcaziotm-cabozantinib-capsules