logo
Share SHARE
FONT-SIZE Plus   Neg

EMA Validates Application For Bristol-Myers' Sprycel In Children With CML

Bristol-Myers Squibb Co. (BMY) said that the European Medicines Agency validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia or CML and to include the powder for oral suspension. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.

The application includes data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel innewly diagnosed chronic phase CML pediatric patients and in pediatric patients resistant to or intolerant of imatinib. Data from this study will be presented at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on Monday, June 5.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Toyota is working on developing an electric car with a fast charging battery, the Chunichi Shimbun reported on Tuesday. Travelers leaving Comic-Con International in San Diego last weekend were in for a rude shock after United Airlines said that comic books were banned in their checked luggage. United Airlines claimed it was a Transportation Security Administration or TSA-mandated rule for all airlines operating out of San Diego over this weekend. A Singapore-based startup wants to make cryptocurrencies like Bitcoin go mainstream and be available for everyday transactions. TenX has built an app that serves as a digital wallet connected to the Visa card. The debit card will instantly convert multiple digital currencies into fiat money such as the dollars, yen and euros.
comments powered by Disqus
Follow RTT