FDA Roundup: Cell Therapy Approval, Warning Issued for At-Home Chemical Peels

FDA Grants Accelerated Approval to First Engineered Cell Therapy for Synovial Sarcoma

FDA Roundup: Cell Therapy Approval, Warning Issued for At-Home Chemical Peels / Grandbrothers - stock.adobe.com

The FDA granted accelerated approval to Adaptimmune Therapeutics for afamitresgene autoleucel (afami-cel [Tecelra]). The drug is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

FDA Warns Against Using At-Home Chemical Peels, Cites Retailers

The FDA has issued a warning to consumers highlighting the dangers of using chemical peel products without proper professional guidance. These products pose a serious risk of skin damage and should only be applied under the supervision of a qualified professional, according to the agency.

FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause

Bayer has submitted a new drug application (NDA) to the FDA for its investigational compound elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist for the nonhormonal treatment of moderate to severe vasomotor symptoms associated with menopause. The therapy, which is in late-stage clinical development, is administered orally once a day and works by modulating estrogen sensitive neurons in the hypothalamus.

FDA Accepts NDA for Suzetrigine to Treat Moderate, Severe Acute Pain

The FDA accepted a new drug application (NDA) for suzetrigine to treat moderate-to-severe acute pain. The therapy, which was granted priority review with a Prescription Drug User Fee Act (PDUFA) date of January 30, 2025, would be the first new class of medicine to treat acute pain in over 20 years if approved.

Ready-to-Use Phosphorus Solution From Amneal Pharmaceuticals Wins FDA Approval

The FDA has issued a New Drug Application approval for Amneal Pharmaceuticals’ presentation of preservative-free potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags. The phosphorus replacement product is indicated as a source of phosphorus to treat hypophosphatemia in adult and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not suitable.

Pancreatic Cancer Dendritic Cell Vaccine Receives FDA Fast Track Designation

A dendritic cell vaccine for the treatment of pancreatic ductal adenocarcinoma has received fast track designation from the FDA. The vaccine technology also previously received both fast track and orphan drug designations for glioblastoma multiforme.

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