J&J: CHMP recommends extended indication for Rybrevant

(CercleFinance.com) - Johnson & Johnson announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of an extended indication for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed), to treat adult patients with advanced non-small cell lung cancer (NSCLC) with exon 19 deletions or L858R substitution mutations after failure of prior treatment with an EGFR tyrosine kinase inhibitor (TKI).


The combination of amivantamab and chemotherapy offers new hope and a new standard of care for these patients, with improvements observed in response rates, progression-free survival and intracranial efficacy, even in patients with previously untreated brain metastases, says the European Institute of Oncology in Milan, Italy.

The CHMP's recommendation for amivantamab is supported by data from a phase 3 study showing that amivantamab + chemotherapy reduces the risk of disease progression or death by 52% compared with chemotherapy alone.


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