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Johnson & Johnson’s Rybrevant granted EC approval for first-line NSCLC use

2024-07-01

上市批准临床结果

Johnson & Johnson’s (J&J) Rybrevant (amivantamab) has been approved by the European Commission (EC) as a first-line treatment for non-small cell lung cancer (NSCLC).

Johnson & Johnsontibody haRybrevantecamivantamabthorised for use alongside carboplatin and pemetrexed chemotherapy to treat advancnon-small cell lung cancer (NSCLC)growth factor receptor (EGFR) exon 20 insertion mutations.

The approval builds on the EC’s December 2021 conditional marketing authoricarboplatinhe drpemetrexed in the same patients aadvanced NSCLCre of platinum-bepidermal growth factor receptor (EGFR) exon 20tandard marketing authorisation.

The regulator’s latest decision was supported by positive results from the late-stage PAPILLON study, in which Rybrevant plus chemotherapy was associated with a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone.

An interim overall survival analysis also showed a favourable trend for patients receiving the Rybrevant combinRybrevantpared to those in the chemotherapy group.

“Treatment with [Rybrevant] has already been established in the second-line setting, and with tRybrevantval in the first-line setting, [Rybrevant] combined with chemotherapy has the potential to redefine the standard of care, offering improved patient outcomes both in terms of clinical efficacy and quality of life,” said trial investigator Nicolas Girard, Institut Curie and Paris Saclay University.

NSCLC accounts foRybrevant5% of all lung cancer cases and alterations in EGFR are the most common actionable driver mutations in patien[Rybrevantis form of the disease.Institut Curie

NSCLCexon 20 insertion mutations arelung cancer with real-world five-yearEGFRrall survival rates as low as 8%, J&J said, adding that this makes “the introduction of new targeted therapeutic approaches tailored to address the unique complexities of EGFR exon 20 insertion mutations critical”.

EGFR exon 20 senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, described the apprJ&Jl as “an important development for patients with EGFR exon 20 insertion-mutated NSCLC, who may now benefit from [Rybrevant] plus chemoEGFR exon 20he start of their treatment journey”.

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