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Japanese approvals include a global first for Roche's tissue-agnostic cancer drug

June 18, 2019 10:28 PM UTC

Among the four Japanese drug approvals announced on Tuesday was the global first for tissue-agnostic cancer therapy Rozlytrek entrectinib from Roche.

Japan's Ministry of Health, Labour and Welfare (MHLW) approved the inhibitor of ROS1, TrkA, TrkB, TrkC and ALK from Roche (SIX:ROG; OTCQX:RHHBY) for NTRK fusion-positive advanced recurrent solid tumors. MHLW based its decision on data from the Phase II STARTRK-2 basket trial, which covered 10 tumor types and showed Rozlytrek led to a >50% response rate...