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FDA grants regular approval to cabozantinib for first-line treatment of advanced renal cell carcinoma

3 Jan 2018

The Food and Drug Administration has granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).

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

This approval was based on data from CABOSUN (NCT01835158), a randomized, open-label phase 2 multicenter study in 157 patients with intermediate and poor-risk previously untreated RCC.

Patients received cabozantinib (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 cabozantinib 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 cabozantinib clinical program 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 cabozantinib were hypertension, diarrhoea, hyponatremia, hypophosphatemia, PPE, fatigue, ALT increased, decreased appetite, stomatitis, pain, hypotension, and syncope.

The recommended dose of cabozantinib 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 cabozantinib have different formulations and are not interchangeable.

Full prescribing information is available here

Source: FDA