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FDA panel recommends approval of T-VEC for metastatic melanoma
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Two FDA committees today expressed support for the approval of talimogene laherparepvec, or T-VEC, for the treatment of patients with metastatic melanoma.
The Oncologic Drugs Advisory Committee and Cellular Tissue and Gene Therapies Advisory Committee voted 22-1 in favor of Amgen’s biologic license application for its oncolytic virus, T-VEC, despite initial controversy about the data. Although the FDA is not obligated to follow the recommendation of its advisory committees, it often does so.
Richard Sherry, MD, a staff clinician in the surgery branch of the National Cancer Institute and a temporary voting member, had the one dissenting vote.
“In clinical research, usually the question is clear and the data is muddy,” Sherry said. “Today, we are in an alternate universe where the data is clear and the question is muddy. Part of the obligation is to define the patient population that this works in, so it looks bad that it’s 22-1 and not unanimous. We know who this works in and it’s not impinging on anyone’s right to practice to let clinicians know. Who is going to look at this data more closely than this group here? Nobody. And who’s going to read the packing insert? I hope some people do, but not many.
This vote is partly on principle, but it’s also pragmatic. This is a chance to make a statement. This drug is not appropriate for the vast majority of patients who have visceral disease. You look at the indications in this trial, and there are no limits … and that to me is not clinically acceptable.”
Patrick Hwu, MD, a professor in the department of melanoma medical oncology in the division of cancer medicine at The University of Texas MD Anderson Cancer Center in Houston, tended to support T-VEC through the day’s session.
“There are patients who have cutaneous or subcutaneous disease who need this [agent],” Hwu said. “I think we should be careful about the way we micromanage the subsets and let physicians be professionals and make the best decisions they possibly can and I really look forward to the future where these combination agents will come down the pike and that will be very exciting.”
Although the other members of the board ultimately voted to recommend T-VEC, many cautioned that concerns raised during the day’s discussions will need to be addressed in the labeling of the drug. However, their decision supports the approval of T-VEC based on the evidence that its benefits outweigh the risks for patients with unresectable melanoma.
After the meeting, Amgen released a statement concerning the outcome of the recommendation.
“Metastatic melanoma continues to be a major challenge to patients and caregivers,” the statement read. “It is a complex and heterogeneous disease that often requires the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for metastatic melanoma is still unacceptably low and nearly 10,000 patients are expected to die in the U.S. this year. It is clear from today’s discussion that the committee recognized the importance of the need for new therapeutic options for patients with metastatic melanoma.
“We look forward to talking with the FDA about how to best make [T-VEC] monotherapy available to patients as they complete their review of the Biologics License Application.”
For more information about today’s decision, please see our additional reporting. – by Anthony SanFilippo