The FDA has granted Fast Track Designation to tamibarotene combined with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) with RARA overexpression, according to a press release from Syros Pharmaceuticals, the manufacturer of the drug.
The combination was approved for adults who are over 75 years of age or have comorbidities that preclude intensive induction chemotherapy.
The oral, first-in-class selective retinoic acid receptor alpha agonist is currently being evaluated in combination with azacitidine and venetoclax in the SELECT-AML-1 clinical trial. Randomized data from an interim analysis showed that the triplet achieved a 100% complete response/complete response with incomplete hematologic recovery (CR/CRi) rate compared with a 70% CR/CRi rate for venetoclax and azacitidine alone.
The safety profile indicated no new toxicities with tamibarotene in combination with azacitidine and venetoclax, and there was no evidence of increased myelosuppression compared with venetoclax and azacitidine alone.