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

Quick Facts

Editors Pick
Stocks recovered from an initial move to the downside but showed a lack of direction over the remainder of the trading session on Monday. The major averages spent most of the day bouncing back and forth across the unchanged line. Internet of Things platform EVRYTHNG is teaming up with IOTA Foundation to use IoT and distributed ledger technology to build a platform to provide transparency and provenance for consumer goods supply chains. EVRYTHNG is an IoT platform that activates every consumer product to make it intelligent, interactive and trackable, while IOTA is focused on DLT and permissionless ecosystem development. Target Corp. has introduced Everspring, a new household essentials brand comprised of more than 70 household essentials items that includes bio-based or recycled materials or natural fibers. The new, in-house brand has been designed by Target with sustainability in mind and is part of its efforts to make products that include ingredients derived from plants or renewable materials more accessible.
Follow RTT