Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Amtagvi Approved to Treat Melanoma

On Feb. 16, 2024, the U.S. Food and Drug Administration (FDA) granted Accelerated Approval for Amtagvi (lifileucel – Iovance Biotherapeutics). It is a tumor-infiltrating lymphocyte (TIL) cell therapy that treats adults who have melanoma that cannot be removed surgically or that has spread. The first cell therapy for a solid cancer will be used after other treatments have failed. Patients will receive one intravenous (IV) infusion at a wholesale acquisition cost (WAC) of $515,000.  Complete prescribing information for Amtagvi is here.

At a Glance

  • Brand (Generic) Name: Amtagvi (lifileucel)
  • Manufacturer: Iovance Biotherapeutics
  • Date Approved: Feb. 16, 2024
  • Indication: to treat adults who have unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor
  • Dosage Forms Available: a single IV infusion containing 7.5 x 109 to 72 x 109 viable cells
  • Launch Date: Immediately
  • Estimated Cost: a one-time cost of $515,000
  • The American Cancer Society estimates that over 100,000 new cases of melanoma are diagnosed each year in the U.S. Although only a small percentage of cases advance into metastases, roughly 8,300 Americans die from melanoma annually.
  • The five-year survival rate for widely metastasized melanoma is around 35%.
  • Amtagvi uses TIL cells from a patient’s tumor, which are cultured in a laboratory for about one month to increase the number of active cells and then infuse them back into the patient.
  • Amtagvi will be used after treatment with a programmed death receptor-1 (PD-1)-blocking antibody, such as Keytruda® (pembrolizumab), fails. If the tumors are positive for BRAF V600 mutations, a BRAF inhibitor such as Braftovi (encorafenib) with or without a MEK inhibitor, such as Mektovi® (binimetinib), also must have been tried.
  • Amtagvi will be administered in about 50 medical facilities that are equipped to perform the procedures and that have staff specially trained to do cell harvesting, infusion, and follow-up.
  • Patients will be hospitalized before and after the infusion and they are advised to stay within a two-hour radius of the treatment facility for several weeks after the procedure.
  • In clinical trials, approximately 30% of patients who received Amtagvi responded to treatment with it (objective response rate, ORR) and the responses averaged at least one year for 44% of responders in one study and 54% in the other one.
  • Amtagvi has a boxed warning because it was responsible for severe side effects including extended and dangerously depressed numbers of blood cells, severe infections, cardiopulmonary problems, kidney damage, and death among study participants.
  • Other side effects, such as diarrhea, fatigue fever, low blood pressure, and rash, were reported by patients in the trials.
  • Designated as an Orphan Drug and a Regenerative Medicine Advanced Therapy, Amtagvi was approved under the FDA’s Fast Track and Priority Review.
  • Since Accelerated Approval for Amtagvi is based on results from uncompleted clinical studies, additional positive results from more advanced trials will be needed before full FDA approval is granted.