On Friday, 15 March, the FDA’s Oncologic Drugs Advisory Committee will meet to discuss Johnson & Johnson (NYSE:JNJ) / Legend Biotech Corporation’s (NASDAQ:LEGN) supplemental biologics license application for Carvykti (ciltacabtagene autoleucel) for relapsed or refractory multiple myeloma, who have received at least one prior line of therapy.
The panel will discuss whether the results of CARTITUDE-4 are sufficient to support a positive risk-benefit assessment of ciltacabtagene-autoleucel (cilta-cel) for the proposed indication.
Specifically, is the risk of early death associated with cilta-cel treatment acceptable in the context of the clinical benefit.
“While the cilta-cel arm demonstrates a benefit after 11 months, the finding is limited by heavy censoring, and the pattern of early deaths attributed to adverse events in the cilta-cel arm is concerning,” the FDA briefing document added.
“More 13% and 22% of deaths occurred in the cilta-cel and standard therapy arms, respectively. However, more deaths due to AEs occurred in the cilta-cel arm (11%) compared to the standard therapy arm (8%) in the safety population,” the staff noted in the document.
HC Wainwright writes that Janssen and Legend have aggressively been building out physical capacity to achieve 10,000 doses of capacity by YE2025.
The HC Wainwright analyst is confident that the companies have maximized their physical capacity. Any constraints on capacity supply will likely stem from challenges in obtaining regulatory approvals necessary for production at the expanded capacity.
The analyst reiterates the Buy rating for Legend Biotech with a price target of $87.
During the afternoon session on Friday, the Committee will discuss an application for a treatment for refractory multiple myeloma.
Bristol-Myers Squibb Co (NYSE:BMY) has submitted a supplemental application for Abecma (idecabtagene vicleucel) for adult patients with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The Committee will discuss the overall survival data in the Study MM-003 (KarMMa-3) and the risk and benefit of idecabtagene vicleucel in the intended population.
Price Action: JNJ shares are down 0.52% at $161.90, and LEGN shares are up 3.94% at $67.70 on the last check Wednesday.
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