Tag Archive for: Carvykti

The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.  

An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.

Despite a new safety warning from the U.S. Food and Drug Administration, J&J still expects its cancer treatment to hit peak sales.

The company forecasted revenue growth of 5-6% for the next year, as it banks on strong demand for cancer treatments Darzalex and Carvykti and resilient sales of blockbuster drug Stelara.

Leaked data from the Phase III CARTITUDE-4 trial showed Johnson & Johnson’s and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) performed much better than expected in patients with multiple myeloma (MM), according to reporting by STAT News.

The company is testing Carvykti in multiple myeloma patients, with a history of relapse, who have stopped responding to existing treatment and have received one to three prior therapies.

End-to-end vector manufacturing optimizes batch success and delivers more doses at lower cost.