Shots:
- The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial
- Approval was based on data from 50 pts across 5 studies, showing a 22% ORR per blinded central review using RANO 2.0 criteria. MDoR (10.3mos.), with 73% responding for at least 6 mos. and 27% for at least 12 mos.
- Modeyso’s safety was assessed in 376 glioma pts across 4 open-label studies, with SAR reported in 33% of pts.
Ref: Jazz Pharmaceuticals | Image: Jazz Pharmaceuticals | Press Release
Related News:- Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)
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