Washington, D.C. — The FDA’s Oncologic Drugs Advisory Committee is set to convene on Friday to deliberate on Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti. This drug is intended for patients with relapsed or refractory multiple myeloma who have undergone previous lines of therapy. The panel will specifically analyze the results of CARTITUDE-4 to determine the risk-benefit assessment of ciltacabtagene-autoleucel (cilta-cel) for this indication.
There is a concern regarding the rate of early deaths associated with cilta-cel treatment, with more deaths reported in the cilta-cel arm compared to the standard therapy arm. HC Wainwright has noted that Janssen and Legend have been actively expanding their physical capacity to meet the demand for this treatment, with a target of achieving 10,000 doses of capacity by the year 2025. The analyst from HC Wainwright expressed confidence in the companies’ ability to optimize their physical capacity.
In addition to discussing Carvykti, the Committee will also review an application for a treatment for refractory multiple myeloma submitted by Bristol-Myers Squibb Co. This application is for Abecma, intended for adult patients with relapsed or refractory multiple myeloma who have received specific prior treatments.
Notably, JNJ shares are currently experiencing a slight decrease in value while LEGN shares have seen an increase. The overall discussions during the meeting will provide crucial insights into the developments and potential approvals of these treatments for multiple myeloma patients. As the FDA’s Oncologic Drugs Advisory Committee convenes, stakeholders eagerly await the outcome of the deliberations surrounding these supplemental biologics license applications.