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Bristol-Myers' Sprycel Gets EC Approval for Label Expansion

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Bristol-Myers Squibb Company BMY announced that the European Commission (EC) has approved the label expansion of oncology drug Sprycel.

Consequently, the drug is now approved for the treatment of children and adolescents aged one year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). It also includes a powder for oral suspension formulation.

An approval was on the cards as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion on the same in April 2018.

The approval was based on positive data from CA180-226 (NCT00777036) study, which evaluated the safety and efficacy of Sprycel in pediatric patients newly diagnosed with CP-CML, and in those who are resistant to or intolerant of Gleevec.

We note that Sprycel is already approved in the United States for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). The drug also received the FDA approval for adults with Ph+ acute lymphoblastic leukemia (ALL), who are resistant to or intolerant of prior therapy. The FDA also approved Sprycel for treatment in pediatric patients with Ph+ CML-CP in November 2017.

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

Bristol-Myers’ shares have declined 6.9% year to date compared with the industry’s decline of 1.1%.


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 causes of concern. In particular, Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq pose stiff competition.

Hence, the label expansion of other drugs of the company should maintain the top-line momentum. The cancer portfolio also got a major boost with the launch of immuno-oncology drug, Empliciti, for the treatment of multiple myeloma in December 2015. Bristol-Myers is co-developing Empliciti with AbbVie ABBV.

Zacks Rank

Bristol-Myers has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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