Weekly Digest - 25-31 Mar 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 25-31 Mar 2023
27 Mar 2023: Pemazyre Oral/ Myeloid/Lymphoid Neoplasms (MLNs) / Incyte: Received MHLW approval in Japan
- Pemazyre’s MHLW approval was based on the Phase 2 FIGHT-203 Myeloid/Lymphoid Neoplasms (MLNs) study
- This approval represents a significant step towards potentially providing a therapeutic option for Japanese patients suffering from this rare condition
- Pemazyre dosed at 13.5 mg orally once daily continuously or intermittently showed promising results
- Complete response rate: 62.5%
- Most common AE: Hyperphosphatemia (70.7%), Alopecia (56.1%)
- Previously, the MHLW granted Orphan Drug Designation (ODD) for Pemazyre to treat MLNs
- In Japan, this designation is granted to the investigational compounds intended to treat rare diseases affecting fewer than 50,000 people
- In Japan, this designation is granted to the investigational compounds intended to treat rare diseases affecting fewer than 50,000 people
