Iovance’s PDUFA date for lifileucel pushed due to FDA backlog
15 Sep 2023
Phase 3Clinical ResultPriority ReviewImmunotherapyPhase 2
Preview
Source: Pharmaceutical Technology
Phalguni Deswal
@Phalguni_GD
Preview
Source: Pharmaceutical Technology
The markets viewed the news favourably, as Iovance’s stock was up by over 15% in pre-market trading. Image Credit: Drozd Irina / Shutterstock.
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 inhibitorsPD-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.
GlobalData is the parent company of Pharmaceutical Technology.
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.