The FDA approved carvykti, a new customized, cell-based treatment from Johnson & Johnson, for the treatment of multiple myeloma, Johnson & Johnson said Feb. 28.
The drug is approved 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.
In one of the U.S. studies on the drug, around 98 percent of the 97 multiple-myeloma patients treated had a significant reduction in the proteins that signal the presence of myeloma, and 83 percent had a complete remission.
"The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up," said Sundar Jagannath, MD, the principal study investigator. "The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time."