BMS’ Onureg (azacitidine) Receives the US FDA’s Approval as Continued Treatment for Acute Myeloid Leukemia

 BMS’ Onureg (azacitidine) Receives the US FDA’s Approval as Continued Treatment for Acute Myeloid Leukemia

BMS’ Onureg (azacitidine) Receives the US FDA’s Approval as Continued Treatment for Acute Myeloid Leukemia

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

Click here ­to­ read full press release/ article | Ref: BMS | Image: BMS

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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