Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee will convene on Friday, March 15th to review Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti, a treatment for relapsed or refractory multiple myeloma patients.
The primary focus of the meeting will be to evaluate the risk-benefit assessment of ciltacabtagene-autoleucel (cilta-cel) based on the results of the CARTITUDE-4 trial. Specifically, the committee will discuss the acceptability of the early death risk associated with cilta-cel treatment in relation to its clinical benefits.
According to the FDA briefing document, concerns have been raised about the higher percentage of deaths attributed to adverse events in the cilta-cel arm compared to standard therapy. Despite this, HC Wainwright analysts believe that Janssen and Legend have made significant progress in expanding their production capacity for Carvykti.
The analyst from HC Wainwright reaffirms their Buy rating for Legend Biotech and sets a price target of $87. They express confidence in the companies’ ability to maximize their physical capacity, with any potential supply constraints likely stemming from regulatory approval challenges for increased production capacity.
In addition to reviewing Carvykti, the Committee will also discuss Bristol-Myers Squibb’s supplemental application for Abecma, another treatment for refractory multiple myeloma patients. The focus will be on evaluating the overall survival data from Study MM-003 (KarMMa-3) and assessing the risk-benefit profile of idecabtagene vicleucel in the target patient population.
On the market front, Johnson & Johnson’s shares are down 0.52% at $161.90, while Legend Biotech’s shares are up 3.94% at $67.70 as of the latest check on Wednesday afternoon. The meeting of the FDA’s Oncologic Drugs Advisory Committee will provide crucial insights into the future of these potential treatments for multiple myeloma patients.