Amgen's Melanoma Drug Talimogene Laherparepvec Lands a Date With the FDA
February 12, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) announced today that it will review the biologics license application (BLA) for Amgen ’s talimogene laherparepvec (T-VEC), an oncolytic immunotherapy for melanoma, on April 29, 2015. The review board will consist of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC).
“The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need," said Sean Harper, executive vice president of Research and Development at Amgen, in a statement. “We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA.”
A company files either a BLA or a New Drug Application (NDA) following the completion of Phase I, II and III clinical trials. A drug needs a BLA as opposed to an NDA when it is derived from living material, either human, animal, or microorganism, rather than chemically synthesized. At the BLA review, the advisory committees will decide if the application is complete. They will also decide if the BLA needs a standard or accelerated review. A standard review means the FDA will review the application for approval within ten months; an accelerated review will take place within six months.
As of now, the Prescription Drug User Fee Act (PDUFA) date, the deadline for the FDA to approve or reject a drug, for T-VEC is currently set for Oct. 27, 2015. The FDA had initially set the date for July 28, 2015, but pushed it back for Amgen to submit additional information, according to Seeking Alpha.
Amgen filed a BLA based on results from a Phase III study of T-VEC called OPTiM, which, “demonstrated a significant extension in durable response rates (DRR)”—its primary endpoint, and a 4.4 month overall survival (OS) as the secondary endpoint. The latter was not found to be statistically significant, according to OncLive, a portal for the oncology community.
The lead investigator of the study, Robert Andtbacka, spoke to OncLive when the results were presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. “Clinically, I think that the 4.4-month difference [in survival] is important for our patients,” Andtbacka, a surgeon and investigator with Intermountain Healthcare and Huntsman Cancer Institute, told OncLive. “However, I think it’s also important to recognize that this is a secondary endpoint, and the study clearly was not powered to look at a small difference, such as this. For me though, clinically, I look at more of what the median survival was for these patients and I also look at the durability of that response.”
The durable response rate of patients, defined as partial or complete response to treatment lasting continuously for at least 6 months, showed a statistically significant improvement in patients treated with T-VEC.
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