J&J: positive CHMP opinion for Lazcluze in lung cancer

(CercleFinance.com) - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization (MA) for Lazcluze (lazertinib) in combination with Rybrevant (amivantamab), for the first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) with EGFR ex19del or L858R mutations.


The CHMP also recommends a type II indication extension for this combination.

These opinions are based on a phase 3 study, showing that the combination reduces the risk of progression or death by 30% compared with osimertinib.

According to Henar Hevia, Senior Director of Oncology at Johnson & Johnson, this treatment could set a new standard by delaying progression while reserving chemotherapy for later stages.


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