Image
a close up of a sign
Advertisement
03/14/2022

Janssen obtains FDA OK for Carvykti

Carvykti provides a treatment for 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.
Sandra Levy
Senior Editor
Sandra Levy profile picture

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.

[Read more: FDA gives Janssen green light for 2 new indications of Xarelto]

"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."

[Read more: Janssen receives FDA green light for Rybrevant]

"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."

    Advertisement
    Advertisement