Alimta + Keytruda and platinum chemo for NSCLC gets FDA label expansion

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Eli Lilly and Co. said FDA has granted approval for a new indication for Alimta (pemetrexed for injection) in combination with Keytruda (pembrolizumab), developed and marketed by Merck, and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

This indication is approved based on data from Merck’s phase III KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival and progression-free survival.

Alimta in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA’s accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and PFS data from the phase II study KEYNOTE-021 (Cohort G1).

In accordance with the accelerated approval process, continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in the KEYNOTE-189 trial and has resulted in the FDA converting the accelerated approval to full approval.

“KEYNOTE-189 demonstrated an exceptional effect of the Alimta-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations,” Anne White, president, Lilly Oncology, said in a statement. “This new indication reinforces Lilly’s continued commitment to providing practice-changing treatment options that can make a meaningful difference for people living with lung cancer.”

Alimta is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed. See additional Important Safety Information below.

On Aug. 20, 2018, Merck’s pembrolizumab was approved by FDA for this indication, based on data from the KEYNOTE-189 study, which demonstrated that treatment with Alimta in combination with pembrolizumab plus platinum-based chemotherapy resulted in significantly longer OS and PFS than Alimta plus platinum chemotherapy with placebo.

Table of Contents

YOU MAY BE INTERESTED IN

Candace S. Johnson leads America’s oldest cancer research center and Jonathan W. Friedberg leads the newest NCI-designated center. Their catchment areas are contiguous, their faculty and staff members collaborate often, and together their institutions embody the culture of NCI-designated cancer centers. 

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception...

The Cancer Letter staff were finalists for nine 2025 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists—seven for journalism; two for design—and won first place for four. The Cancer Letter’s entries recognized by SPJ include investigative journalism, series, breaking news, features, photojournalism, commentary, illustration, and front page design. This is...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login