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Bristol Myers Gets FDA Approval for Oral AML Therapy Onureg

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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved its oral hypomethylating agent, Onureg (azacitidine 300 mg tablets) for continued treatment of acute myeloid leukemia (“AML”). Onureg has been approved for use in patients who achieve first complete remission ("CR") or complete remission with incomplete blood count recovery (CRi), following intensive induction chemotherapy, and who are not able to complete intensive curative therapy.

The approval was based on data from the pivotal phase III study — QUAZAR AML-001 — evaluating Onureg as maintenance treatment in patients with newly-diagnosed AML who achieved CR or CRi following a chemotherapy. Data from the study showed that maintenance treatment with Onureg resulted in a highly statistically significant and clinically meaningful improvement in overall survival (“OS”) compared to placebo. Median OS was 24.7 months for Onureg versus 14.8 months for placebo. The key secondary endpoint of relapse-free survival ("RFS") also showed a statistically significant improvement.

Please note that Bristol Myers added Onureg to its pipeline with the acquisition of Celgene in November 2019. With this approval, the drug becomes the first and only FDA-approved continued AML therapy for patients in remission. The drug is under review in Europe for a similar indication.

Shares of the company have declined 5% year to date against the industry’s increase of 2.7%.

We note that AML is a type of cancer in which the bone marrow makes abnormal blast cells. AML progresses rapidly and is typically fatal within weeks or months if left untreated.

Per the press release, approximately 20,000 new cases of AML are estimated to be diagnosed in 2020 and the disease is expected to take 11,180 lives. Moreover, AML’s response may be of short duration following initial chemotherapy, leading to relapse of the disease. This represents a significant unmet need for continued therapy options that can prolong overall survival and likely boost prospects for oral Onureg.

Zacks Rank & Stocks to Consider

Currently, Bristol Myers is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the biotech sector are Merck (MRK - Free Report) , Horizon Therapeutics (HZNP - Free Report) and QIAGEN (QGEN - Free Report) . While Horizon Therapeutics and QIAGEN sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merck’s earnings per share estimates have increased from $5.45 to $5.70 for 2020 and from $5.79 to $5.93 for 2021 over the past 30 days. The company delivered four-quarter average earnings surprise of 12.66%.

Horizon Therapeutics’ earnings per share estimates have increased from $2.00 to $2.86 for 2020, and from $3.05 to $4.29 for 2021 in the past 30 days. The company beat estimates in each of the trailing four quarters, the average being 38.63%. The stock has surged 108.5% so far this year.

QIAGEN’s earnings per share estimates moved up from $1.88 to $2.08 for 2020 and from $2.00 to $2.34 for 2021 over the past 30 days. The company delivered four-quarter earnings surprise of 2.27%, on average. Year to date, the company’s shares have gained 50.1%.

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