FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

July 31, 2020

Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines, according to a press release from Roche.

The supplemental Biologics License Application (sBLA) for Tecentriq was granted under priority review.  The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.

The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death, compared to placebo plus Cotellic and Zelboraf. The most common adverse reactions in patients who received Tecentriq plus Cotellic and Zelboraf were rash (75 percent), musculoskeletal pain (62 percent), fatigue (51 percent), hepatotoxicity (50 percent), pyrexia (49 percent), nausea (30 percent), pruritus (26 percent), edema (26 percent), stomatitis (23 percent), hypothyroidism (22 percent), and photosensitivity reaction (21 percent).

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