Array, which makes targeted small molecule drugs for treating cancer, launched its only commercial medicine, Braftovi plus Mektovi, as a treatment for BRAF-mutant melanoma, last year. The approval was based on clinical response data from SCLC cohorts of the phase Ib KEYNOTE-028 and phase II KEYNOTE-158 studies. While Keytruda already holds a strong position in the non-small cell lung cancer market, this is the first approval for the drug in the SCLC indication, which accounts for 10% to 15% of all lung cancers. The regulatory filing was based on data from the phase III SOLO-1 study. AstraZeneca also won approval from Japan’s regulatory body for PT010, its investigational triple-combo inhaler and Bevespi Aerosphere, its fixed-dose LABA/LAMA inhaler, both to treat COPD. Roche’s Personalized Medicine Entrectinib Gets Approval in Japan: Japan’s regulatory authority granted marketing approval to Roche’s personalized medicine entrectinib for adult and pediatric patients with NTRK fusion-positive advanced recurrent solid tumors.
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