Shots:

• The approval is based on P-III QUAZAR AML-001 study assessing Onureg (300 mg- PO) vs PBO  for 14 days of a 28-day cycle + BSC in a ratio (1:1) in 472 patients aged ≥55yrs. with AML and had achieved CR or Cri following intensive induction CT and cannot proceed intensive curative therapy including HSCT
• The P-III QUAZAR AML-001 study results: m-OS (24.7 vs 14.8mos.); m-DOR (12 vs 6 cycles). Additionally- the therapy has received the US FDA’s PR designation while EMA validates its MAA in May’2020
• Onureg (CC-486) is an oral hypomethylating agent that incorporates into DNA and RNA and carries out hypomethylation of DNA- as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow

­ Ref: BMS | Image: BMS