The U.S. Food and Drug Administration (FDA) has accepted the filing of Eagle Pharmaceutical’s new drug application (NDA) for its novel ready-to-dilute Alimta (pemetrexed injection) chemotherapy drug for the treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) and mesothelioma.
The chemotherapy drug (25 mg/mL) works by inhibiting the synthesis of nucleotides that make up DNA strands, stopping the cells from dividing and leading to their death.
The NDA seeks approval of the ready-to-dilute Alimta as a monotherapy for metastatic non-squamous NSCLC, and in combination with Platinol (cisplatin) for mesothelioma patients.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has until Oct. 30 this year to complete its review of Eagle’s NDA and make a decision.
Eagle’s NDA is for a multidose formulation of pemetrexed that can be readily diluted and used for the same indications of the Alimta powder formulation marketed by Eli Lilly and Company.
If approved, the new Alimta product would be administered through intravenous infusion, but the powder is already dissolved in the saline solution. It only needs to be further diluted to reach the appropriate concentration.
In 2004, the FDA approved Alimta powder in combination with Platinol to treat malignant pleural mesothelioma patients. That approval was based on data from a multicenter, randomized trial that showed superior effectiveness in patients treated with Alimta plus Platinol compared to patients receiving Platinol alone.
Eagle CEO Scott Tarriff said the company was pleased the FDA accepted the NDA filing of its ready-to-dilute Alimta injection. “We look forward to the FDA’s decision in October 2017, and intend to work closely with the FDA through the review process,” he said in a press release.
In related news, a completed Phase 2 clinical trial (NCT00738582) in unresectable mesothelioma patients evaluated a combination of the chemotherapies Alimta and Platinol (cisplatin) with the anti-mesothelin antibody amatuximab.
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