Amtagvi Approved by the FDA for Treatment of Advanced Melanoma

Agency approves one-time cell therapy for patients who have progressed after initial standard-of-care therapies
Amtagvi Approved by the FDA for Treatment of Advanced Melanoma
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TUESDAY, Feb. 20, 2024 (HealthDay News) -- Amtagvi (lifileucel) has been approved by the U.S. Food and Drug Administration for the treatment of advanced melanoma. Amtagvi becomes the first cellular therapy approved to treat this form of solid tumor cancer.

"The approval of Amtagvi offers hope to those with advanced melanoma who have progressed following initial standard-of-care therapies, as the current treatment options are not effective for many patients," Samantha Guild, president of AIM at the Melanoma Foundation, said in an Iovance Biotherapeutics news release. "This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options."

With the treatment, doctors surgically remove tissue from the patient's tumor and grow immune cells from that tissue in the lab. Then, they infuse those new immune cells into the patient, where they attack and kill the cancer.

In a trial involving 73 patients treated with Amtagvi, the response rate was 31.5 percent, with three patients having a complete response and 20 patients experiencing a partial response, the FDA said. Among patients who responded to Amtagvi, 56.5, 47.8, and 43.5 percent had no tumor progression or did not die at six, nine, and 12 months, respectively, the agency added.

However, the treatment will carry a boxed warning that says Amtagvi can cause a severe low blood count, severe infection, and cardiovascular problems, the FDA noted. Other risks associated with the treatment relate to the surgery used to extract cancerous tissue and the seven days of intense chemotherapy the patient must have before getting Amtagvi. Other side effects can include chills, fever, tiredness, a fast heart rate, diarrhea, fever, rash, and hair loss. Most side effects subside in the first few weeks. 

Approval of Amtagvi was granted to Iovance Biotherapeutics.

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