FDA Approves PEMFEXY® Combination Therapy for Metastatic Non-Small Cell Lung Cancer
Key Insights
Eagle Pharmaceuticals' PEMFEXY® gains FDA approval for use with pembrolizumab and platinum chemotherapy in metastatic non-squamous NSCLC patients without EGFR (search) or ALK (search) aberrations.
PEMFEXY®, a ready-to-dilute liquid formulation, now holds the same indications as ALIMTA®, offering advantages like eliminating reconstitution steps.
This marks the fifth indication for PEMFEXY®, expanding its role in treating non-squamous NSCLC and mesothelioma (search), enhancing Eagle's oncology portfolio.
Eagle Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (search) (NSCLC) with no EGFR (search) or ALK (search) genomic tumor aberrations.
PEMFEXY® is a ready-to-dilute (RTD) liquid intravenous formulation developed to eliminate the reconstitution step required for ALIMTA®, the Listed Drug (LD).
Clinical Significance
This approval marks a significant advancement in the treatment landscape for metastatic non-squamous NSCLC. The combination of PEMFEXY® with pembrolizumab and platinum chemotherapy offers a new first-line treatment option for patients without EGFR (search) or ALK (search) aberrations, addressing a critical need in this patient population.
Commercial Implications
"With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle’s hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents."
Background on PEMFEXY®
In February 2020, Eagle received FDA approval for PEMFEXY, following a settlement agreement of patent litigation with Eli Lilly and Company in December 2019. The agreement allowed for an initial market entry of PEMFEXY in February 2022 and a subsequent uncapped entry on April 1, 2022.