Incyte Receives CHMP Positive Opinion of Tabrecta (capmatinib) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer
Shots:
- The EMA’s CHMP has issued a positive opinion recommending marketing authorization for capmatinib as a monothx. in adults with advanced NSCLC harboring alterations leads to METex14 skipping
- The CHMP opinion was based on the P-II (GEOMETRY mono-1) study evaluating capmatinib (400mg, PO, BID) which showed ORR (51.6%) in 31 patients with Tabrecta as 2L therapy in METex14 skipping pretreated population & (44.0%) in 100 previously-treated patients
- The expansion cohort analysis showed an m-DoR of 9.7mos., m-OS (13.6mos.), m-PFS (5.5mos.) in prior-treated patients & 6.9mos. for patients who received Tabrecta as 2L therapy, DCR (82.0%), manageable safety profile with no new safety signals
Ref: Businesswire | Image: Incyte
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