FDA Approves Genentech's Tecentriq, Cotellic, Zelboraf for BRAF V600-Mutated Melanoma

NEW YORK – The US Food and Drug Administration on Thursday approved the combination of three Genentech drugs, the immune checkpoint inhibitor atezolizumab (Tecentriq), the MEK inhibitor cobimetinib (Cotellic), and the BRAF inhibitor vemurafenib (Zelboraf), for the treatment of BRAF V600-mutated advanced melanoma. 

The agency previously approved Roche's qPCR-based cobas 4800 BRAF V600 Mutation Test as a companion diagnostic for detecting BRAF V600E or BRAF V600K mutations in melanoma patients to determine eligibility for combination treatment with cobimetinib and vemurafenib. 

The latest approval of the three-drug regimen is based on results from the 514-patient Phase III IMspire150 study, in which patients randomized to receive the atezolizumab-cobimetinib-vemurafenib regimen had significantly improved progression-free survival compared to patients who received cobimetinib-vemurafenib and placebo. The median progression-free survival in the atezolizumab-cobimetinib-vemurafenib group was 15.1 months versus 10.6 months in comparator arm.

The atezolizumab-treated group also had an improvement in duration of response. Patients treated with the three-drug regimen achieved a median duration of response of 21 months compared to 12.6 months in the placebo group.

The most common adverse reactions to the atezolizumab-containing treatment were rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.

Novartis also competes in this space with its BRAF inhibitor dabrafenib (Tafinlar) and MEK inhibitor trametinib (Mekinist). Last year, Novartis launched a free BRAF testing program through Quest Diagnostics in hopes of closing access gaps.