Saturday, February 8, 2025

FDA Review of Iovance’s Melanoma Cell Therapy Faces Delay, Promising Expedited Approval

Similar articles

Iovance Biotherapeutics is facing a three-month delay in the FDA’s review of its lifileucel cell therapy for melanoma in the US due to “insufficient resources” at the agency. The new decision date has been extended from November 25th to February 24th next year. Iovance stated that the FDA has indicated it will expedite the remaining review for a potentially earlier approval date.

The biotech filed its tumor-infiltrating lymphocyte (TIL) therapy lifileucel as a one-time, personalized therapy for advanced melanoma patients in May. It was granted a priority six-month review by the FDA, with no need for an advisory committee meeting. The delay is attributed to a capacity issue in handling the response to a request for additional information.

Subscribe Weekly Market Access News

* indicates required

Iovance emphasized that the priority review remains intact, with no major issues identified in the marketing application. The company is a leader in developing cell therapies for solid tumors, similar to the success seen with CAR-T therapies in hematological cancers.

The therapy, lifileucel, is unique as it does not require genetic modification but is exposed to IL-2 to activate it, making the manufacturing process shorter. The filing is based on results from the C-144-01 study, which demonstrated a 36% objective response rate and a 36-month duration of response in advanced melanoma patients who had progressed on prior therapies.

Despite some questions about its durability in follow-up data, lifileucel represents a potential blockbuster in the melanoma treatment landscape. The delay caused a dip in Iovance’s shares, but they rebounded as investors responded positively to the FDA’s willingness to expedite the review process.


This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article