Skip to main content
main-content
Top

10-11-2022 | FDA | News

approvalsWatch

First-line cemiplimab–chemo approved for advanced NSCLC in USA

Author: Shreeya Nanda

share
SHARE
print
PRINT
insite
SEARCH

medwireNews: Cemiplimab-rwlc plus chemotherapy can be used as a first-line treatment option for US patients with advanced non-small-cell lung cancer (NSCLC), following a positive decision by the FDA.

The PD-1 inhibitor in combination with platinum-based chemotherapy is indicated for adults lacking EGFR, ALK, or ROS1 alterations who have not received prior systemic therapy for advanced disease.

The decision is based on the EMPOWER-Lung 3 trial (also known as Study 16113), which showed a significant improvement in the primary endpoint of overall survival as well as the secondary endpoints of progression-free survival and objective response rate with the addition of cemiplimab to first-line chemotherapy in this patient population.

The FDA recommends that cemiplimab be given intravenously at a dose of 350 mg every 3 weeks.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

share
SHARE
print
PRINT