Bristol-Myers' Sprycel Gets European Nod for Label Expansion

Bristol-Myers Squibb Company BMY announced that the European Commission (EC) has approved its oncology drug Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The approval includes both the tablet form of Sprycel and, the powder for oral suspension (PFOS) formulation of the drug in a first for pediatric patients with ALL in Europe.

The FDA approved Sprycel for the same indication in January 2019. This is the second pediatric leukemia indication for Sprycel in Europe. It received an approval in July 2018 by the EC for the treatment of pediatric patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).

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.

We note that Sprycel is already approved in the United States for the treatment of adults with Ph+ CML in 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 of pediatric patients with Ph+ CML-CP in November 2017.

Approval of new drugs and label expansion of existing drugs bode well for Bristol-Myers. The stock has decreased 18.4% in the past year, against the industry’s growth of 9.6%. 


While its blockbuster drug, Opdivo continues to perform well and 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 Keytruda and Roche’s RHHBY Tecentriq pose stiff competition. Hence, the label expansion of other drugs of the company should help 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.

In a separate release, Bristol-Myersannounced new results from the phase III CheckMate-214 study, wherein therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to Opdivo plus low-dose Yervoy continued to show a significant overall survival (OS) benefit compared to those randomized to Pfizer’s PFE) Sutent (sunitinib).

Zacks Rank

Bristol-Myers carries a Zacks Rank #2. (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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