FDA has approved Janssen Biotech’s Lazertinib (Lazcluze) in combination with Amivantamab-vmjw (Rybrevant) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
This approval was based on results from the MARIPOSA clinical trial for Lazertinib in combination with Amivantamab-vmjw offering hope for patients with NSCLC.
The FDA Oncology Center of Excellence reviewed Lazertinib combined with Amivantamab-vmjw for NSCLC as part of its Project Orbis initiative.
In this review, the FDA worked alongside the Australian Therapeutic Goods Administration (TGA), Brazil’s Health Regulatory Agency (ANVISA), Health Canada, Switzerland’s Swissmedic, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
Lazertinib plus Amivantamab-vmjw was granted priority review for treating NSCLC.
Healthcare professionals were advised to report any serious adverse events suspected of using the Lazertinib and Amivantamab-vmjw combination in NSCLC patients to the FDA’s MedWatch Reporting System.
Source: FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer?utm_medium=email&utm_source=govdelivery
