Bristol Myers Gets FDA Approval for Oral AML Therapy Onureg

Bristol Myers Squibb announced that the U.S. FDA has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia …

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FAQs about Bristol Myers Gets FDA Approval for Oral AML Therapy Onureg Coupon?

Is onureg effective for adults with acute myeloid leukemia (AML)?

“Continued treatment with Onureg demonstrated an overall survival benefit in adults with AML who had achieved first complete remission in the QUAZAR® AML-001 study and, notably, it has the potential to do this in a convenient manner, given its once daily oral formulation,” said QUAZAR AML-001 lead investigator Dr. Andrew Wei in a press release. ...

Is azacitidine (onureg) safe for patients with acute myeloid leukemia?

The FDA has approved oral azacitidine (Onureg, CC-486) for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy. 1 ...

What is onureg ® used for?

ONUREG ® is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ...

Can onureg ® be used to treat MDS?

Treatment of MDS with ONUREG ® is not recommended outside of controlled trials. ONUREG ® can cause fetal harm when administered to a pregnant woman. Azacitidine caused fetal death and anomalies in pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m 2 basis. ...

How effective is onureg for CR / CRI?

Patients (n=472) who achieved CR or CRi with intensive induction chemotherapy with or without receiving subsequent consolidation therapy were randomized 1:1 to receive Onureg 300 mg (n=238) or placebo (n=234) orally on days 1 to 14 of each 28-day cycle. The main efficacy outcome measure was overall survival (OS). ...

Does onureg improve overall survival?

The approval was based on data from the randomized, double-blind phase 3 QUAZAR AML-001 trial, which demonstrated that Onureg showed a significant and meaningful improvement in overall survival, which was the main goal of the study. ...