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BASEL (dpa-AFX) - Novartis (NVS) said Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting ....
The positive opinion from the CHMP is based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated ....
Opinion based on Phase II GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with advanced ....
Tabrecta (capmatinib) showed a median overall survival (OS) of 20.8 months in treatment-naïve patients and 13.6 months in previously-treated patients in first published mature data1,2 Tabrecta achieved ....