FDA Grants Regular Approval to Cabozantinib

It is indicated in first-line treatment of advanced renal cell carcinoma

On 19 December 2017, the US Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC).

The FDA previously approved Cabometyx in 2016 for treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Current approval provides for treatment in the first-line setting.

This approval was based on data from CABOSUN (NCT01835158), a randomised, open-label phase II multicentre study in 157 patients with intermediate and poor-risk previously untreated RCC. Patients received Cabometyx (n = 79) 60 mg orally daily or sunitinib (n = 78) 50 mg orally daily (4 weeks on treatment followed by 2 weeks off) until disease progression or unacceptable toxicity.

Estimated median progression-free survival (as assessed by blinded independent radiology review committee) for patients taking Cabometyx was 8.6 months (95% CI: 6.8, 14.0) compared with 5.3 months (95% CI: 3.0, 8.2) for patients taking sunitinib (Hazard ratio 0.48; 95% CI: 0.31, 0.74; p = 0.0008).

The most commonly reported (≥25%) adverse reactions in the Cabometyx clinical programme are diarrhoea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia, weight decreased, vomiting, dysgeusia, and stomatitis. 

The most frequent grade 3-4 adverse reactions (≥5%) in patients treated with Cabometyx on CABOSUN were hypertension, diarrhoea, hyponatremia, hypophosphatemia, PPE, fatigue, ALT increased, decreased appetite, stomatitis, pain, hypotension, and syncope.

The recommended dose of Cabometyx is 60 mg orally, once daily.

Cabozantinib is also approved for the treatment of medullary thyroid cancer and is marketed under the trade name Cometriq. Cometriq and Cabometyx have different formulations and are not interchangeable.

Full prescribing information is available here.

FDA granted priority review to Cabometyx for this application.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.