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Bristol-Myers Squibb Company BMY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion on the label expansion of oncology drug Sprycel.
The CHMP recommended approval of the drug in combination with chemotherapy, to include the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission (EC) in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in pediatric patients and patients who cannot swallow tablets.
The EC will now review the recommendation but is not bound by it.
The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union (EU).
The company’s supplemental Biologics License Application (sBLA) for the same indication is under review in the United States. The FDA action date is Dec 29, 2018.
We note that Sprycel is already approved in the United States for the treatment of adults with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). The drug also received the FDA approval for adults with Ph+ ALL who are resistant to or intolerant of prior therapy. The FDA also approved Sprycel’s label expansion to include pediatric patients with Ph+ CML-CP in November 2017 and the European Commission approved the same in July 2018.
Concurrently, Bristol-Myers Squibb, Eisai Co., Ltd. and its U.S.-based precision medicine research & development subsidiary H3 Biomedicine, Inc. announced a multi-year research collaboration. The companies will focus on novel therapeutics generating from H3’s RNA splicing platform and evaluate if these can provide a more powerful response against cancer.
The collaboration will explore modulating RNA splicing to develop potential first-in-class therapies that would direct the immune system to target cancer cells and help more patients experience the benefits of immunotherapy.
Per the terms, H3 and Bristol-Myers will jointly conduct the research, focusing on developing immune therapies using H3’s RNA splicing platform. While the former will be responsible for development and commercialization of selected compounds, the latter is entitled to receive an upfront payment along with development, regulatory and sales milestones, and certain royalties according to sales revenue after launch. On the other hand, Eisai retains an option to co-develop and co-commercialize certain compounds that emerge from the collaborative research effort.