After the FDA questioned the safety of two CAR-T therapies, members of the agency's Oncologic Drugs Advisory Committee voted unanimously to recommend Carvykti, made by Janssen Biotech, and voted 8-3 in favor for Abecma, from Bristol-Myers Squibb K.K.
Carvykti is now recommended by the panel, for "treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and who are refractory to lenalidomide," according to a March 15 news release from Janssen.
"As a physician and researcher committed to advancing patient care, the potential of Carvykti in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma," Jordan Schecter, MD, the vice president, disease area leader for multiple myeloma at Johnson & Johnson Innovative Medicine, said in the release.
Abecma was also recommended by the panel — which came just one day after the FDA granted accelerated approval to Breyanzi — another CAR-T therapy made by Bristol-Myers Squibb for "treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitors," according to a news release.
Those who voted in opposition of Abecma during the ODAC meeting said they worried its risks could outweigh the benefits.
"Our goal is to help patients experience life better… the questions here on the risk benefit ratio, the risks are on [progression-free survival] and with the data we have now it appears transient and there is no clear evidence that early intervention [of CAR-T therapies] is better," one member of the committee remarked.
The committee met March 15 to review data on the two different CAR-T therapies for which the agency found links to increased rates of early death. It spent half of the day reviewing data and patient testimony for Carvykti and the other half reviewing Abecma.
The FDA's investigation into CAR-T therapies was initially prompted by 22 reports of patients contracting blood cancer after receiving CAR-T therapy treatments. The agency subsequently called for warning labels on all commercial CAR-T therapy products amid its investigation, and in January it sent letters to six manufacturers to inform them. Both Janssen and Bristol-Myers Squibb were among those recipients.
Both drugs now await full approval from the FDA.