Citius Pharmaceuticals looks to refile former Eisai cancer drug in early 2024

Citius Pharmaceuticals plans to refile its experimental drug for a rare blood cancer in early 2024 following an FDA rejection in July.

Leonard Mazur

The drug, Lymphir, is a reformulated version of Eisai’s cutaneous T-cell lymphoma (CTCL) treatment Ontak, which was voluntarily pulled from the US market in 2014 over manufacturing issues. Citius CEO Leonard Mazur told Endpoints News on Friday that “there’s no relationship” between those issues and the FDA’s recent complete response letter.

The July CRL was due “primarily to final product testing” and validations that were not complete in time for the original filing, and had nothing to do with safety or efficacy, Mazur said. The FDA has not required any further clinical testing and Citius plans to complete the FDA’s requests by the end of 2023.

If all goes well, Mazur is preparing to resubmit Lymphir’s application in early 2024 and is hoping for a launch in the “early second half” of that year.

Citius acquired Dr. Reddy’s exclusive license to Lymphir from Eisai in 2021. The company paid Dr. Reddy’s $40 million upfront and promised a variety of sales and commercial milestones, including up to $40 million more for development milestones related to CTCL approvals in the US and other countries. Citius’ license covers development and commercialization rights worldwide, excluding Japan and certain parts of Asia.

CTCL is a rare and typically slow-growing form of cutaneous non-Hodgkin lymphoma (NHL) that starts in white blood cells. Citius’ application is for the treatment of patients who’ve received at least one prior systemic therapy.

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