Janssen obtains FDA OK for Carvykti
The Food and Drug Administration has given Janssen permission for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
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"We are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like Carvykti as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma," Peter Lebowitz, global therapeutic area head, oncology, Janssen Research & Development, said. "We extend our sincere gratitude to the patients, their families and the teams of researchers and study centers who have participated in the clinical study of Carvykti and enabled today's approval."
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"This approval of Janssen's first cell therapy is a testament to our continuing commitment in oncology to deliver new therapeutic options and drive toward our vision of the elimination of cancer," Mathai Mammen, executive vice president, pharmaceuticals, Janssen Research & Development, said. "Today's approval underscores our determination to develop therapies that can help patients living with what remains an intractable blood cancer today and at the same time offer hope for the future."