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FDA Okays Genentech's Tecentriq Plus Cotellic And Zelboraf To Treat Advanced Melanoma

Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration approved Tecentriq plus Cotellic and Zelboraf 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, the company said.

The supplemental Biologics License Application 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 most common adverse reactions (rate 20%) in patients who received Tecentriq plus Cotellic and Zelboraf were rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.

The company noted that it has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary,
skin, breast, gastrointestinal, gynecological and head and neck cancers.

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