Rafael Pharmaceuticals’ Devimistat (CPI-613) Receives EMA’s ODD for R/R Acute Myeloid Leukemia (AML) and Metastatic Pancreatic Cancer (mPC)
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
Click here to read full press release/ article | Ref: Globenewswire | Image: Linkedin