FDA Expands Drug's Label With Combo Therapy for First-Line NSCLC Treatment

Officials with the FDA have expanded the label of pemetrexed for injection (Alimta, Eli Lilly) in combination with pembrolizumab (Keytruda, Merck) and platinum chemotherapy, according to a press release.

With this approval, pemetrexed plus pembrolizumab is indicated for use along with platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Pemetrexed in combination with pembrolizumab and carboplatin was previously approved under the FDA’s accelerated approval process, with full approval contingent upon data demonstrating clinical benefit, according to Eli Lilly.

The approval of the new indication is based on results from Merck’s phase 3 KEYNOTE-189 trial. The study evaluated pemetrexed in combination with pembrolizumab and cisplatin or carboplatin compared with pemetrexed in combination with placebo and cisplatin or carboplatin in 616 untreated patients with metastatic nonsqumaous NSCLC, regardless of PD-L1 expression.

A version of this article was originally published by Specialty Pharmacy Times. Read the full article at SpecialtyPharmacyTimes.com.

Reference

FDA Expands Lilly’s Alimta (pemetrexed) Label with Combination of Keytruda (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatmnt of Metastatic Nonsquamous Non-Small Cell Lung Cancer [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/fda-expands-lillys-alimtar-pemetrexed-label-combination. Accessed January 31, 2019.