Azacitidine for injection (Vidaza®) is now available in China.
The nucleoside metabolic inhibitor was approved in China to treat patients with intermediate-2/high-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) with 20% to 30% bone marrow blasts, and chronic myelomonocytic leukemia (CMML).
Azacitidine for injection is marketed in China by BeiGene Ltd. under an exclusive license from Celgene Corporation.
“Vidaza is the only approved hypomethylating agent shown to prolong survival for patients with MDS and the first new treatment for MDS patients approved in China since 2009,” said John V. Oyler, founder, chief executive officer, and chairman of BeiGene.
“We are excited to announce that the first prescription was made in January 2018. From now on, Chinese patients can benefit from Vidaza in hospitals around China.”
Azacitidine was evaluated in a global phase 3 trial of patients with intermediate-2- and high-risk MDS, CMML, or AML (AZA-001). Results from this trial were published in The Lancet Oncology in 2009.
Patients were randomized to receive azacitidine plus best supportive care (BSC, n=179) or conventional care regimens plus BSC (105 to BSC alone, 49 to low-dose cytarabine, and 25 to chemotherapy with cytarabine and anthracycline).
Azacitidine was given subcutaneously at a dose of 75 mg/m2 daily for 7 consecutive days every 28 days until disease progression, relapse after response, or unacceptable toxicity.
The median overall survival was 24.5 months with azacitidine, compared to 15 months for patients treated with conventional care regimens.
There was a higher hematologic response rate in the azacitidine arm than the conventional care arm—29% and 12%, respectively.
In the azacitidine group, 45% of patients who were dependent on red blood cell transfusions at baseline became transfusion independent, compared with 11% in the conventional care group.
Forty-six percent of patients in the azacitidine arm and 63% in the conventional care arm died.
Grade 3/4 hematologic toxicity (in the azacitidine and conventional care arms, respectively) included neutropenia (91% and 76%), thrombocytopenia (85% and 80%), and anemia (57% and 68%).