Velsipity (Etrasimod) for UC; Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC; Patisiran in ATTR amyloidosis; Digital Health Advisory Committee

New FDA Approvals

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Here are the highlights:

Velsipity (Etrasimod) for UC: The FDA has approved Velsipity (etrasimod) for treating moderate to severe active ulcerative colitis (UC) in adults. Etrasimod, an oral medication manufactured by Pfizer, was based on safety and efficacy data from the ELEVATE UC 52 and ELEVATE UC 12 trials, making it the second S1P class agent approved for UC in the United States. The first agent, ozanimod (Zeposia), received FDA approval in May 2021.

Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC:The FDA has granted approval for the combination of encorafenib and binimetinib to treat BRAF V600E–mutant, metastatic non–small cell lung cancer (NSCLC). The approval, supported by the phase 2 PHAROS study, showed a 75% objective response rate (ORR) in treatment-naive patients. This combination was previously approved for unresectable or metastatic melanoma with a BRAF mutation.

Edison System for Non-Invasive Destruction of Liver Tumors:The FDA has authorized the marketing of the HistoSonics Inc. Edison System for non-invasive destruction of liver tumors. The system utilizes a non-thermal, mechanical process of focused ultrasound to create small, vapor-filled cavities (cavitation) without heat, mechanically destroying and liquefying targeted liver tissue, including tumors. This technology is suitable for patients with sufficient functional liver reserve.

Complete Response Letter for Patisiran ATTR amyloidosis:The FDA declined to approve patisiran for ATTR amyloidosis despite a favorable recommendation from advisers. The FDA noted that patisiran did not significantly improve the condition of patients with heart muscle issues or cardiomyopathy caused by ATTR amyloidosis. Patisiran, branded as Onpattro, is already approved to treat nerve damage in adult patients with hereditary ATTR amyloidosis.

FDA Creates a Digital Health Advisory Committee:The FDA has established a Digital Health Advisory Committee to address complex issues related to digital health technologies, including AI/ML, augmented reality, virtual reality, and more. This committee will provide expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with digital health technologies and is expected to be fully operational in 2024.

Intro and outro music

Garden Of Love by Pk jazz Collective