FDA approves Carvykti to treat r/r multiple myeloma following four lines of therapy.

The approval for cilta-cel was based on findings from the phase 1b/II CARTITUDE-1 trial (NCT03548207), in which cilta-cel elicited an objective response rate (ORR) of 98% (95% CI, 92.7%-99.7%) in this patient population. Additionally, the stringent complete response rate (sCR) was 78% (95% CI, 68.8%-86.1%). The median duration of response (DOR) was 21.8 months at a median 18 months of follow-up.

“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,” principal investigator Sundar Jagannath, MD, director of the Center of Excellence for Multiple Myeloma and professor of medicine, hematology and medical oncology, at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, stated in a press release. “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.”