Janssen seeks EMA marketing nod for Lazertinib plus Rybrevant for EGFR-Mutated Non Small Cell Lung Cancer

Belgium: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.

“Despite significant advances in the treatment of EGFR-mutated non-small cell lung cancer, the progression-free survival rate with the current first-line therapies remains low,” said Catherine Taylor, Vice President, EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. “Novel targeted therapies are necessary to address resistance and disease progression, and provide new options for patients in this area of high unmet medical need.