EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia
Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia and to the powder for oral suspension.
BMS has announced that the European Medicines Agency (EMA) has validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1-18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (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.
“Treatment options for pediatric patients with chronic phase CML, along with formulations that support the unique demands of children with cancer continue to be unmet needs,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Building on our long-standing heritage in hematology, including the use of Sprycel for more than a decade to treat adults with certain forms of CML, the validation of this application supports our commitment to expand options for children and adolescents with different types of cancer.”
The application includes data from CA180-226 (NCT00777036), an ongoing Phase II, open-label, non-randomized trial studying Sprycel in newly 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 5 June.
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...