Bristol Myers Squibb (BMY) has announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets) for the continued treatment of adults with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
AML is one of the most common acute leukemias in adults. There will be nearly 20,000 new cases of acute myeloid leukemia in the United States this year, accounting for 1.1% of all cancer cases, with an estimated 11,180 deaths resulting from the disease.
The approval is based on results from the pivotal Phase 3 QUAZAR AML-001 study in which treatment with Onureg resulted in a statistically significant and clinically meaningful improvement in overall survival (OS), the study’s primary endpoint, of nearly 10 months compared to placebo.
Median OS from time of randomization was greater than two years among patients who received Onureg compared to 14.8 months among patients receiving placebo. Onureg was continued until disease progression or unacceptable toxicity, with serious adverse reactions occurring in 15% of patients.
“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 Andrew Wei of Alfred Hospital and Monash University, Melbourne, Australia.
“This approval should help establish continued treatment with Onureg as a standard component of AML therapy for adults who achieved first complete remission following chemotherapy and who cannot proceed to intensive curative therapy, like hematopoietic stem cell transplant” he added.
The New Drug Application was granted Priority Review Designation by the FDA, with a Marketing Authorization Application (MAA) validated by the European Medicines Agency in May 2020.
Shares in BMY are down 5% year-to-date, but analysts are retaining a bullish Strong Buy consensus on the stock’s outlook. That’s with an average analyst price target of $69 indicating 14% upside potential from current levels.
“We see BMY on track for solid long-term growth due to a healthy pipeline. Inrebic, a novel myelofibrosis drug, was approved in August, while 6 more novel approvals are expected until the end of the year” commented CFRA analyst Sel Hardy.
With a $70 price target on the stock, Hardy sees upside potential of 15%, adding “We think the stock offers considerable upside and we maintain our positive outlook as we see the Celgene deal creating a faster-growing company with a less concentrated drug portfolio despite the emergence of the Covid-19 pandemic.”
BMY acquired Celgene Corporation in November 2019, in one of the largest pharma deals to date. According to Hardy, the deal combined two companies with valuable overlap in the oncology, immunology, and inflammation therapeutic areas. (See BMY stock analysis on TipRanks)
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