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
McDonald's Corp. has announced the return of its popular Shamrock Shake milkshake for a limited time at participating U.S. restaurants nationwide. The minty green milkshake is made with McDonald's vanilla soft serve blended with Shamrock Shake syrup and topped with whipped topping. It first debuted on the McDonald's menu in 1970 and has been a seasonal tradition for nearly 50 years. Asia-focused lender HSBC, through its blockchain-powered platform, has reduced the cost of settling foreign exchange trades by 25 percent, Reuters reported quoting a bank executive overseeing the project. Mark Williamson, chief operating officer of FX cash trading and risk management, told that the bank processes between 3,500 and 5,000 trades a day on its "FX Everywhere" system. PepsiCo, Inc. (PEP) reported fourth-quarter core EPS of $1.49 compared to $1.31, prior year. Excluding the impact of foreign exchange translation, core constant currency EPS increased 17 percent year-over-year. On average, 19 analysts polled by Thomson Reuters expected the company to report profit per...
Follow RTT