Approvals· Brief · November 13, 2026, 7:00 AM ET

CHMP adopts positive opinion on Aumseqa

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a marketing authorization for Aumseqa, a 55 mg film-coated tablet intended for first-line treatment of adult patients with advanced NSCLC harbouring EGFR exon 19 deletions or L858R mutations, and for treatment of EGFR T790M mutation-positive NSCLC. The applicant for the medicinal product is SFL Pharmaceuticals Deutschland GmbH.

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