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Wired News - The European Commission Approves Expanded Indication for Bristol-Myers Squibb's Sprycel

LONDON, UK / ACCESSWIRE / July 9, 2018 / If you want access to our free research report on Bristol-Myers Squibb Co. (NYSE: BMY), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BMY as the Company's latest news hit the wire. On July 05, 2018, the Company announced that the European Commission (EC) has approved the indication for Sprycel (dasatinib) to treat children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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In April 2018, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use issued a positive opinion. The approval makes Sprycel the first ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in pediatric patients and patients who cannot swallow tablets.

EC Approval Based on Data from CA180-226 Trial

The EC's approval is based on data from CA180-226 (NCT00777036), which is the largest prospective trial evaluating the safety and efficacy of Sprycel in pediatric patients newly diagnosed with CP-CML, and in those resistant to, or intolerant of, imatinib. In the Phase-2 CA180-226 trial, at minimum two-year follow-up, patients with CP-CML resistant to, or intolerant of, imatinib who received Sprycel demonstrated a cumulative major cytogenetic response (MCyR) rate of 55.2%, three months into treatment, exceeding the defined threshold of clinical interest for the primary endpoint of the cohort and increasing over time to greater than 90% at 24 months.

Newly diagnosed patients with CP-CML who received Sprycel as a tablet or as powder for oral suspension achieved a cumulative complete cytogenetic response (CCyR) rate, the primary endpoint in the cohort, of 64% as early as 6 months into treatment, exceeding the defined threshold of clinical interest and increasing over time to 94% at 24 months. The secondary endpoint of estimated progression-free survival at 48 months was greater than 75% for patients resistant to, or intolerant of, imatinib and greater than 90% for patients who received Sprycel as a first-line therapy. Sprycel was shown to have a comparable safety profile in pediatric patients with CP-CML to that reported in adults with CP-CML.

About Chronic Myeloid Leukemia (CML)

CML is a type of cancer that affects the blood and bone marrow. In CML, the bone marrow produces too many white cells called granulocytes. These cells gradually crowd the bone marrow, interfering with normal blood cell production. They also spill out of the bone marrow and circulate around the body in the bloodstream. As they are not fully mature, they are unable to work properly to fight infections. Over time, a shortage of red cells and platelets can cause anemia, bleeding, and/or bruising. CML usually develops gradually during the early stages of disease, and progresses slowly over weeks or months.

About Sprycel (Dasatinib)

Sprycel first received the US Food and Drug Administration (FDA)'s approval in 2006 for the treatment of adults with Ph+ CML in chronic phase, who are resistant, or intolerant, to prior therapy including imatinib. At that time, Sprycel also received the FDA's approval for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant, or intolerant, to prior therapy. Sprycel is approved and marketed for these indications in more than 60 countries. Sprycel is also an FDA-approved treatment for adults with newly diagnosed Ph+ CML-CP; and in November 2017, Sprycel received the FDA's approval for the expanded indication for treatment in pediatric patients with Ph+ CML-CP. The adult indication is approved in more than 50 countries.

About Bristol-Myers Squibb Co.

Headquartered in New York City, New York, Bristol-Myers Squibb is a global biopharmaceutical organization focused on discovering, developing, and delivering innovative medicines for patients with serious diseases.

Stock Performance Snapshot

July 06, 2018 - At Friday's closing bell, Bristol-Myers Squibb's stock climbed 1.09%, ending the trading session at $56.56.

Volume traded for the day: 4.27 million shares.

Stock performance in the last month – up 6.88%; and past twelve-month period – up 2.32%

After last Friday's close, Bristol-Myers Squibb's market cap was at $92.36 billion.

Price to Earnings (P/E) ratio was at 24.36.

The stock has a dividend yield of 2.83%.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers - Major industry. This sector was up 1.4% at the end of the session.


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