J&J: CHMP greenlights subcutaneous Rybrevant

(CercleFinance.com) - Janssen-Cilag International NV announces that the Committee for Medicinal Products for Human Use (CHMP) of the EMA (European Medicines Agency) has recommended the extension of the marketing authorization for the subcutaneous formulation of Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) as first-line treatment for adults with advanced NSCLC with specific EGFR mutations (i.
e. non-small cell lung cancer), and as monotherapy after failure of platinum-based chemotherapy for EGFR exon 20 mutations.

A Phase III study confirmed the non-inferiority of this formulation compared with the intravenous version, with a reduction in administration time and infusion-related reactions.

We look forward to bringing this new treatment option to patients in Europe, while pursuing our ambition to transform results in EGFR-mutated NSCLC, it said.


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