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Bristol-Myers' Sprycel Seeks Label Expansion in the U.S.

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA accepted its supplemental Biologics License Application (sBLA) for oncology drug, Sprycel.

The sBLA seeks to get Sprycel’s label expansion for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy. 

The application was based on positive data from an ongoing phase II trial, CA180-372 (NCT01460160), evaluating the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.

The FDA action date is Dec 29, 2018.

We note that Sprycel is already approved in the United States for the treatment of adults with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). The drug also received the FDA approval for adults with Ph+ ALL, who are resistant to or intolerant of prior therapy. The FDA also approved Sprycel’s label to include pediatric patients with Ph+ CML-CP in November 2017 and the European Commission approved the same in July 2018.

Label expansion of existing drugs bode well for Bristol-Myers.

Bristol-Myers’ shares have declined 0.9% year to date compared with the industry’s gain of 5.2%.


While its blockbuster drug, Opdivo continues to perform well and the label expansion of the drug will further boost the top line, pricing concerns and stiff competition in the immuno-oncology space are major concerns. In particular, Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq pose stiff competition.

Hence, the label expansion of other drugs of the company should maintain the top-line momentum.

Eliquis is also expected to drive further growth in 2018, driven by increases in market share in the novel oral anticoagulant (NOAC) market.

Zacks Rank and Other Stock to Consider

Bristol-Myers has a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the pharma/biotech sector is Gilead Sciences, Inc. (GILD - Free Report) , which sports a Zacks Rank #1 as well. You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates have increased from $6.11 to $6.58 for 2018 in the last 60 days. Estimates for 2019 are also up by 12 cents.

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