Hutchmed's Amdizalisib (HMPL-689) Receives Breakthrough Therapy Designation for the Treatment of R/R Follicular Lymphoma in China
Shots:
- The NMPA has granted BTD to amdizalisib for the treatment of r/r FL
- The preliminary results from the ongoing P-Ib expansion study showed that the therapy was well- tolerated- exhibit dose-proportional PK- manageable toxicity profile- clinical activity in r/r B-cell lymphoma & results will be presented at ESMO 2021. Currently- the company gains all rights to amdizalisib globally
- The therapy is also being evaluated in an ongoing P-I/Ib study for patients with r/r NHL in the US & EU. In April’21- the company has initiated a P-II registration study for amdizalisib in ~100 patients with r/r FL & ~80 patients with MZL across 35 sites in China
| Ref: Hutchmed | Image: Globe Newswire
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