Voquenza for GERD, ADI-270 for Clear Cell Renal Cell Carcinoma, Lomecel-B in AD, ART26.12 for Chemotherapy-Induced Peripheral Neuropathy, Test for Candida auris, Botensilimab/balstilimab in mCRC

New FDA Approvals

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• The FDA has approved vonoprazan (Voquenza) for treating non-erosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is an oral potassium-competitive acid blocker (PCAB) already approved for erosive esophagitis and Helicobacter pylori infection. PCABs are a new class of medicines that inhibit stomach acid secretion.
• Non-erosive GERD is the most common form of GERD, affecting around 45 million US adults, with about 15 million treated with prescription medication annually. Many patients remain dissatisfied with existing treatments, experiencing symptoms that affect their quality of life.
• The approval of vonoprazan was based on the Phalcon-Nerd-301 study, a Phase 3 trial showing it significantly reduced heartburn episodes and provided more heartburn-free days and nights compared to placebo. The trial included 772 adults with frequent heartburn, demonstrating vonoprazan's effectiveness over placebo.
• The FDA has granted fast track designation to ADI-270 for metastatic or advanced clear cell renal cell carcinoma (ccRCC) in patients who previously received an immune checkpoint inhibitor and a VEGF inhibitor. ADI-270 is a CD70-targeted gamma delta CAR T-cell therapy designed to enhance resilience to the tumor microenvironment.
• A phase 1/2 trial will evaluate ADI-270 in patients with confirmed ccRCC who have been previously treated. The primary endpoints are the incidence of dose-limiting toxicities and the proportion of treatment-emergent adverse effects.
• The FDA has granted Fast Track and Regenerative Medicine Advanced Therapeutic (RMAT) designations to Lomecel-B, an investigational MSC therapy for Alzheimer’s disease (AD). Lomecel-B aims to address neurodegeneration in AD and showed positive results in the CLEAR MIND Phase 2a trial.

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