CAR-T Digest- August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest- August 2020
National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) for ciltacabtagene autoleucel
05 Aug 2020
Ciltacabtagene autoleucel (Cilta-cel; LCAR-B38M CAR-T cells; BCMA targeting CAR-T) – Johnson & Johnson/ Legend Biotech
- The first investigational product being recommended for BTD in China for the treatment of adults with relapsed or refractory multiple myeloma (RRMM)
- BTD is based on the ongoing Phase 2 CARTIFAN-1 study (China), the ongoing Phase 1b/2 CARTITUDE-1 (US and Japan), and Phase 1, first-in-human (FIH) LEGEND-2 study (China)
J&J’s Cilta-cel becomes the first CAR-T to bag breakthrough designation in China
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CI Scientists Remarks:
- In Dec’17, Legend Biotech entered into a worldwide collaboration and license agreement with Johnson & Johnson, to jointly develop and commercialize Cilta-cel in patients with RRMM
- Cilta-cel got a BTD status in Dec’19 in the US. Also has orphan drug designation (ODD) from the major regulatory authorities
- In China, two studies CAR-TIFAN-1 (Phase 2, confirmatory) and LEGEND-2 (Phase 1, FIH) are being conducted in patients with RRMM
- BLA filing expected by late 2020 in US and early 2021 in EU and now in China
- Legend Biotech will use the data from the Phase 2 CARTIFAN-1 trial to support regulatory approval
– Dr. Kowndinya, CI Scientists