EMA CHMP adopts positive opinion for Tabrecta in METex14 advanced NSCLC

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The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion and recommended granting marketing authorization for Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

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Follow-up results from the phase Ib/II CHRYSALIS-2 study cohort evaluating the safety and tolerability of the combination of Rybrevant (amivantamab-vmjw)—a bispecific antibody targeting epidermal growth factor receptor and mesenchymal-epithelial transition—with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor, plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer and EGFR mutations, showed that the drug combination led to durable progression-free survival.