Johnson & Johnson has garnered expanded approvals from Europe’s regulator for two of its cancer treatments.
First up, the European Commission has given the green light to Dacogen (decitabine) for newly diagnosed or secondary acute myeloid leukaemia in patients over 65 who are not candidates for standard induction chemotherapy. The drug is already approved for myelodysplastic syndromes more than 35 countries including the USA, Brazil and China.
The latest approval is based on a Phase III trial that compared Dacogen to a patient’s choice of either supportive care or low-dose cytarabine in the treatment of older patients with AML. The results demonstrated an increase of 54% in median overall survival in patients taking Dacogen (7.7 months compared to 5.0 months) and an updated analysis of mature survival data “confirmed this strong trend”, said J&J’s Janssen-Cilag unit.
Dacogen was developed by Astex Pharmaceuticals which licensed the drug to Eisai which in turn sold rights outside of North America to J&J. Astex receives royalties from Eisai on the global sales for any indication starting at 20%, up to a maximum of 30%.
The EC has also approved J&J’s subcutaneous version of Velcade (bortezomib) for multiple myeloma.
The authorisation is based on data from a Phase III study demonstrating that subcutaneous administration of the drug is equally effective as already-approved intravenous bortezomib “but is associated with a significant reduction in the frequency and severity of side effects”, J&J said. It also offers greater convenience.
