The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024.
The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024.
However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting.
The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at $1.16bn.
Lifileucel is a one-time tumour-infiltrating lymphocyte (TIL) therapy. Iovance is seeking approval for the therapy as a second-line treatment after anti-PD-1/L1 inhibitors and targeted therapies for patients with advanced melanoma.
Globaldata forecasts global sales of $959m for lifileucel in 2029. The drug is also being evaluated in other solid tumour indications such as recurrent head and neck cancer squamous cell carcinoma and non-small cell lung cancer.
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Iovance reported that all pre-approval inspections of clinical sites, manufacturing and testing facilities have been successfully completed.
Lifileucel’s BLA is supported by a Phase II clinical trial (NCT02360579) and an open-label Phase III confirmatory clinical trial (NCT05727904), which compares the combination therapy of Merck & Co. (MSD)’s Keytruda (pembrolizumab) and lifileucel with the Keytruda monotherapy in patients with untreated, unresectable, or metastatic melanoma.
The preliminary data from the trial was presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022. The data showed an overall response rate (ORR) of 31.4%, with nine and 39 patients showing complete and partial responses, respectively.