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Bristol-Myers' (BMY) Sprycel Gets FDA Nod for Label Expansion

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved a label expansion of the oncology drug, Sprycel.

Sprycel tablets are now approved for the treatment of pediatric patients aged one year or older, with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), in combination with chemotherapy. The FDA reviewed the company’s application on a priority-review basis. The approval came on the back of positive data from a phase II study, CA180-372 (NCT01-460160), which evaluated Sprycel tablets in combination with chemotherapy in 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL. Sprycel plus chemotherapy demonstrated a three-year event-free survival benefit.

The latest approval makes Sprycel the only second-generation tyrosine kinase inhibitor approved for this patient population. 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 expansion to include pediatric patients with Ph+ CML-CP in November 2017 and the European Commission approved the same in July 2018.

In December 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of the drug in combination with chemotherapy, to include the treatment of pediatric patients with newly diagnosed Ph+ ALL. The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission (EC) in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in pediatric patients and patients who cannot swallow tablets.

Approval of new drugs and label expansion of existing drugs bode well for Bristol-Myers. The stock has decreased 16.4% in the last six months, against the industry’s growth of 9.7%.


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.

Another drug of Bristol-Myers, Eliquis is also expected to drive growth, owing to increases in market share in the novel oral anticoagulant (NOAC) market.

Zacks Rank & Key Pick

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Novartis (NVS - Free Report) , which sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ earnings per share estimates increased from $5.50 to $5.53 for 2019 over the past 60 days.

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