Roche announced that the U.S. Food and Drug Administration (FDA) has approved its PD-L1 monoantitic Tecentriq joint MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelmurabraf for the treatment of patients with braF V600 mutation-positive advanced melanoma.
the BRAF protein mutates in almost all melanoma patients.
Photo Source: The approval is based on the results of a three-phase study of Imspire150, a combination of treatments that improved patients' median progression-free survival (PFS) to 15.1 months, compared with 10.6 months for the placebo group. Levi Garraway, chief medical officer of
Roche Genentech, said: "With the combination of cancer immunotherapy and targeted therapy, braF V600 mutant-positive patients with advanced melanoma can survive for more than 15 months without worsening the disease.
FDA approval of the Tecentriq portfolio is an important step in the treatment of advanced melanoma.
" however, Roche could face stiff competition from rival Merck's Keytruda and Baxter's Opdivo, which have been on the market for years as drugs to treat melanoma.
Keytruda was approved for the treatment of advanced melanoma as early as September 2014, when it became the first drug in the U.S. to be approved for PD-1/L1.
Opdivo was also approved in 2015 to treat patients with advanced melanoma.
in addition to melanoma, Roche's Tecentriq is also in the lung cancer, urogenital tract, skin, breast cancer, gastrointestinal, gynaecological and head and neck cancer is undergoing or planned several phase 3 studies.