Novartis is going full steam ahead with the company’s cancer development efforts, posting positive results from two ongoing trials for lymphoma and leukemia.
The U.S. Food and Drug Administration approved Novartis’ first-in-class Scemblix (asciminib) for two indications in the treatment of chronic myeloid leukemia (CML).
Japanese biopharmaceutical firm Takeda Pharmaceutical announced that the company’s drug candidate for leukemia failed to meet the primary endpoint in a late-stage study.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical’s supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
Novartis drug candidate asciminib notched a trial win against Pfizer’s Bosulif as the Swiss drugmaker pushes to expand medicines for chronic myeloid leukemia in patients for whom other treatments stopped working.
The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
The U.S. FDA declined to approve Daiichi Sankyo Co.’s drug quizartinib as a treatment for adults with a type of blood cancer.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.
The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.