Washington, DC – On Friday, the FDA’s Oncologic Drugs Advisory Committee is set to convene to review Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti for the treatment of relapsed or refractory multiple myeloma. The discussion will focus on the efficacy and safety of ciltacabtagene autoleucel, also known as cilta-cel, in patients who have undergone at least one prior line of therapy.
One key point of contention will be the balance between the clinical benefits of cilta-cel and the associated risks, particularly the risk of early death. The panel will analyze data from the CARTITUDE-4 trial to determine if the benefits outweigh the potential adverse events linked to cilta-cel treatment.
According to the FDA briefing document, there are concerns regarding the pattern of early deaths attributed to adverse events in the cilta-cel arm compared to the standard therapy arm. Analysts from HC Wainwright have noted that Janssen and Legend Biotech have made significant efforts to expand their physical capacity to meet the demands for cilta-cel, aiming for 10,000 doses by the end of 2025. The companies are confident in their ability to ramp up production, with any potential supply constraints likely stemming from regulatory approval hurdles.
In addition to the discussion on Carvykti, the Committee will also evaluate an application from Bristol-Myers Squibb Co for Abecma, another treatment for relapsed or refractory multiple myeloma. This application specifically targets adult patients who have previously received certain other treatments for the disease.
As the discussions unfold on Friday, market watchers will be keeping an eye on the stock movements of JNJ and LEGN. While JNJ shares have seen a 0.52% decline, LEGN shares have surged by 3.94% on the latest check on Wednesday.
Overall, the FDA’s meeting on Friday will play a crucial role in shaping the future landscape of treatments for relapsed or refractory multiple myeloma, offering insights into the efficacy and safety profiles of emerging therapies in the space.