Regulatory Tracker FDA: 19th September 2024
BriaCell Unveils FDA-Approved EAP for Metastatic Breast Cancer Treatment
BriaCell Therapeutics has received U.S. FDA authorization for its Expanded Access Policy (EAP) to offer Bria-IMT™, an innovative immunotherapy, to metastatic breast cancer (MBC) patients who are not eligible for the company’s ongoing Phase 3 clinical trial. The EAP was approved as part of BriaCell’s Fast Track designation and aims to provide access to this potentially lifesaving treatment to patients in need. Bria-IMT™, combined with an immune checkpoint inhibitor, has shown promising survival benefits for patients who have exhausted other treatment options. BriaCell’s leadership hopes this novel approach will bring new hope and improve outcomes for MBC patients.
Engrail Therapeutics Begins Phase 1 Clinical Trial for ENX-104
Engrail Therapeutics has launched a Phase 1 clinical trial for ENX-104, a dopamine D2/D3 receptor antagonist designed to treat major depressive disorder (MDD) characterized by anhedonia, a core symptom marked by the inability to experience pleasure. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ENX-104 in healthy volunteers, with the goal of addressing anhedonia, which remains largely unresponsive to existing antidepressants. The randomized, double-blind, placebo-controlled study involves 48 participants across multiple dose cohorts to explore how ENX-104 enhances dopamine neurotransmission by inhibiting presynaptic autoreceptors. This marks an important milestone for Engrail’s clinical-stage programs, including ENX-102 for generalized anxiety disorder, as the company continues to focus on precision-targeted therapies aimed at treating neuropsychiatric and neurodevelopmental conditions underserved by current medical treatments.
Vivos Therapeutics Secures FDA 510(k) Clearance for Pediatric Sleep Apnea Treatment
Vivos Therapeutics has received FDA 510(k) clearance for its DNA appliance, designed to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children aged 6 to 17. This clearance marks a significant breakthrough in pediatric OSA treatment, as up to 10.1 million U.S. children suffer from this condition, often linked to other health issues like ADHD, anxiety, and obesity. Unlike traditional surgical approaches, Vivos’ non-invasive device offers a safer, more effective alternative that promotes better outcomes for children. With this regulatory approval, Vivos is positioned to capture a significant share of the pediatric OSA market and implement its strategic marketing model to scale quickly through collaborations with healthcare professionals. Clinical trials have shown promising results, significantly reducing snoring and OSA symptoms, providing new hope for millions of children and their families.
Merck Secures Clearance for KEYTRUDA combined with pemetrexed and platinum chemotherapy
The FDA has approved Merck’s KEYTRUDA® (pembrolizumab) combined with pemetrexed and platinum chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This decision is based on the Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated that KEYTRUDA plus chemotherapy significantly improves overall survival by 21%, progression-free survival, and overall response rate compared to chemotherapy alone. This approval marks KEYTRUDA’s first indication for MPM in the U.S., offering a new treatment option for this difficult-to-treat cancer.
