logo
Plus   Neg
Share
Email

Bristol-Myers: European Commission Approves Sprycel Plus Chemotherapy

Bristol-Myers Squibb Co. (BMY) said that the European Commission or EC has approved Sprycel, or dasatinib, in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia or ALL.

This is the second pediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension or PFOS formulation of Sprycel.

The approval is based on data from CA180-372 (NCT01460160), a Phase 2 trial which evaluated 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.

Results from the CA180-372 trial presented at the 2017 American Society of Hematology Annual Meeting showed that at three years, the combination of Sprycel and chemotherapy demonstrated an event-free survival or EFS rate, the study's primary endpoint, of 65.5 percent, and an overall survival or OS rate of 91.5 percent.

The safety profile of Sprycel administered in combination with chemotherapy in pediatric patients with Ph+ ALL in the CA180-372 trial was consistent with the known safety profile of Sprycel in adults with Ph+ ALL and the known safety profile of the chemotherapy regimen.

"We are proud that the approval by the European Commission brings children with Ph+ acute lymphoblastic leukemia a new treatment option, including a powder formulation developed as part of our commitment to addressing the unique needs of children with cancer," said Fouad Namouni, head of oncology development, Bristol-Myers Squibb.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration or FDA announced on its website that pharma major Pfizer, Inc. issued recall of two lots of tablets meant to treat acute migraine in adults for concerns over bacteria infection. The pharma company is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets for potential presence of Genus Pseudomonas and Burkholderia bacteria. Cosmetics company Revlon Inc. (REV) is reportedly considering a potential sale of parts or all of its business. According to Bloomberg, Revlon has retained financial advisers from Goldman Sachs Group Inc. to explore strategic alternatives. No deal has been reached yet, but Revlon is exploring all... China's Lenovo Group Ltd. warned it may have to raise prices of its products if the U.S. moves ahead with the decision to impose additional tariffs on Chinese goods, according to a report by Reuters. The warning by Lenovo, the world's largest PC maker, comes amid the escalating trade war between the U.S. and China that has raised concerns about the global economic outlook.
Follow RTT