- Legend Biotech ( NASDAQ: LEGN ) said on Monday that China's National Medical Products Administration (NMPA) accepted its new drug application (NDA) seeking approval for ciltacabtagene autoleucel (cilta-cel) to treat a type of blood cancer.
- The NDA was backed by data from a phase 2 trial called CARTIFAN-1 in China which evaluated cilta-cel in adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug.
- "We look forward to the possibility of providing a new treatment option for appropriate patients with relapsed and refractory multiple myeloma in China," said Legend CEO Ying Huang.
- Cilta-cel is approved and marketed as Carvykti by Legend and Johnson & Johnson ( NYSE: JNJ ) in the U.S., the EU and Japan.
For further details see:
J&J, Legend Biotech's Carvykti for multiple myeloma gets review in China