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

Written by Ruchika Sharma Published On 2023-12-25T15:30:53+05:30 | Updated On 25 Dec 2023 3:31 PM IST

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.

MARIPOSA (NCT04487080) is a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib compared to osimertinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The MARIPOSA study met its primary endpoint, resulting in statistically significant and clinically meaningful improvement in progression-free survival (PFS) for amivantamab plus lazertinib versus osimertinib, as assessed by blinded independent central review (BICR). The safety profile of amivantamab plus lazertinib was consistent with prior reports of the combination, with mostly Grade 1 or 2 adverse events (AEs).

“Lung cancer remains the leading cause of cancer death worldwide and high unmet needs remain for patients with certain oncogenic driver mutations,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research and Development, LLC. “We’re pleased to announce the submission of lazertinib, in combination with amivantamab as a chemotherapy-free regimen, in the first-line, common EGFR-mutated NSCLC setting, to the European Medicines Agency. Once again, this shows our commitment to advancing innovative therapies that have the potential to be a future standard of care.”

The pivotal data from the MARIPOSA study were featured in a Late-Breaking Presidential Symposium session (Abstract #LBA14) at the 2023 European Society of Medical Oncology (ESMO) Congress.

Read also: JnJ seeks USFDA nod for Rybrevant plus Lazertinib for EGFR-Mutated Non-Small Cell Lung Cancer

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751