Rafael Pharmaceuticals' Devimistat (CPI-613) Receives EMA's ODD for R/R Acute Myeloid Leukemia (AML) and Metastatic Pancreatic Cancer (mPC)
Shots:
- The ODD designation is based on the study results assessing devimistat + high dose cytarabine & mitoxantrone and devimistat + folfirinox in patients with r/r AML and mPC respectively
- R/R AML study results: CR + Cri (52%); mOS (12.4 mos.)- mPC study results: ORR (61%); mOS (19.9 mos.); mPFS (9.9 mos.)- with safe results as monothx and in combination+ SoC drugs respectively
- Devimistat (CPI-613) is a novel AMD (altered Metabolism Directed) based drug targeting cancer cells and has received ODD from the US FDA for pancreatic cancer- AML- MDS- peripheral T-cell lymphoma and Burkitt lymphoma. Devimistat is being evaluated in seven trials for hematological malignancies and solid tumors
Ref: Globenewswire | Image: Linkedin
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