Lifileucel for Melanoma, Iloprost for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide for EOE, Tricuspid Regurgitation, ACE2016, Human Acellular Vessel (HAV)

New FDA Approvals

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• Lifileucel for Melanoma: Lifileucel (Amtagvi) has received accelerated FDA approval for unresectable metastatic melanoma in adults previously treated with specific inhibitors, marking it as the first FDA-approved T cell therapy for solid tumor cancer. The therapy involves collecting and expanding a patient's own T cells from their tumor for reinfusion, demonstrating a 31.5% objective response rate in a global study. A phase 3 trial is in progress to confirm its clinical benefit.
• Iloprost Injection for Frostbite: The FDA approved Aurlumyn (iloprost) injection, the first-ever treatment for severe frostbite in adults to reduce amputation risk. Iloprost, a vasodilator, showed effectiveness in an open-label trial of 47 adults, offering a significant advancement in managing severe frostbite.
• MDMA-Assisted Therapy for PTSD: The FDA is considering a new drug application for MDMA-assisted psychotherapy for PTSD, a potential first federal approval of its kind. Supported by two Phase 3 clinical trials showing safety and efficacy, this therapy represents a novel treatment avenue for severe PTSD.
• NALIRIFOX for Pancreatic Cancer: NALIRIFOX, a combination chemotherapy regimen, has been approved as a first-line treatment for metastatic pancreatic cancer, the first such approval in over a decade. Demonstrating a survival benefit in phase 3 trials, NALIRIFOX offers a new standard for previously untreated patients.
• Tepotinib for NSCLC: The FDA has fully approved tepotinib (Tepmetko) for NSCLC with MET exon 14 skipping alterations, following accelerated approval in 2021. The approval is based on significant response rates and median overall survival benefits shown in the VISION trial.
• Omalizumab for Food Allergies: Omalizumab (Xolair) injection is the first FDA-approved medication to reduce the severity of allergic reactions to multiple foods from accidental exposure. Approved for patients aged 1 year and older, it's based on phase 3 trial results showing significant efficacy in preventing reactions to common allergens.
• Budesonide Oral Suspension for EOE: The FDA approved budesonide oral suspension (Eohilia) as the only oral therapy for eosinophilic esophagitis in patients 11 years and older. This approval offers a specific treatment option for EoE, a chronic disease causing esophageal inflammation and related symptoms.
• TriClip® for Tricuspid Regurgitation: The FDA approved the TriClip™ TEER system by Abbott for minimally invasive treatment of tricuspid regurgitation, a first-of-its-kind device. Based on the TRILUMINATE trial, the TriClip showed significant improvements in patients' condition and quality of life.
• ACE2016 for Solid Tumors: The FDA cleared the IND application for ACE2016, an allogeneic gamma delta 2 T cell therapy targeting EGFR-expressing solid tumors. Set to begin in 2024, this Phase 1 trial will evaluate ACE2016's safety, tolerability, and pharmacodynamics.
• Human Acellular Vessel (HAV) for Vascular Trauma: The FDA granted Priority Review for Humacyte's BLA for the HAV for urgent arterial repair in vascular trauma cases. Supported by clinical trial and real-world evidence, the HAV offers a bioengineered alternative for arterial repair without the need for immune suppression.

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