Silver Spring, Maryland – On Friday, the FDA’s Oncologic Drugs Advisory Committee will convene to review Johnson & Johnson and Legend Biotech Corporation’s joint application for Carvykti, a treatment for patients with relapsed or refractory multiple myeloma. This particular session aims to assess the risks and benefits of Carvykti, specifically looking at the results of the CARTITUDE-4 trial to determine its efficacy in this patient population.
The main focus of the discussion will be on the risk of early death associated with Carvykti treatment, compared to the potential clinical benefits it offers. The FDA’s briefing document highlighted concerns about the number of deaths attributed to adverse events in the Carvykti arm, indicating a need for further evaluation of the treatment’s safety profile.
HC Wainwright, a renowned healthcare analyst, emphasized the efforts of Janssen and Legend in expanding their manufacturing capacity to meet the increasing demand for Carvykti. The analyst expressed confidence in the companies’ ability to maximize their production capacity, projecting potential challenges in obtaining regulatory approvals for expanded manufacturing.
In addition to Carvykti, the Committee will also discuss Bristol-Myers Squibb Co’s application for Abecma, another treatment for refractory multiple myeloma. The discussion will revolve around the overall survival data from the Study MM-003 (KarMMa-3) and the risk-benefit analysis of Abecma in the target patient population.
As the discussions unfold, market reactions to these developments are noticeable, with JNJ shares experiencing a slight decrease while LEGN shares see an uptick. These fluctuations reflect the anticipation and uncertainty surrounding the FDA’s decision on these groundbreaking treatments for multiple myeloma.
Overall, the FDA’s advisory committee meeting holds significant importance for the future of treating relapsed or refractory multiple myeloma, as stakeholders await crucial insights into the efficacy and safety profiles of Carvykti and Abecma. The decisions made during this meeting will undoubtedly impact the landscape of multiple myeloma treatment options and provide hope for patients battling this challenging disease.