J&J cancer drugs get EU approval
pharmafile | October 2, 2012 | News story | Sales and Marketing | Cancer, Dacogen, EU, J&J, JJ, Velcade
Two of Johnson & Johnson’s key cancer drugs have been shown the green light from the European Commission.
Janssen-Cilag International’s Dacogen has been approved to treat acute myeloid leukaemia (AML), while the same company’s multiple myeloma treatment Velcade has also received marketing authorisation in a new delivery mode.
Dacogen (decitabine), which has orphan drug designation in AML, can be used to treat patients aged 65 and above with newly-diagnosed de novo or secondary cases of the disease, and who are not candidates for standard induction chemotherapy.
Patients with this aggressive, fast-growing cancer tend to be in their sixties, and standard chemotherapy leads to a high 30-day mortality, making it an unattractive or unworkable option for many.
Dacogen is already licensed the treatment of myelodysplastic syndromes in more than 35 countries worldwide.
Its approval in AML was based on the Phase III DACO-016 trial, which showed an increase of 54% in median overall survival (OS) in patients taking decitabine, versus those on either supportive care or low-dose cytarabine.
Median OS in the Dacogen arm was 7.7 months versus 5.0 months in the comparator arm.
Meanwhile Janssen’s injectable version of Velcade (bortezomib) has been approved in the EU to treat multiple myeloma, an incurable blood cancer that starts in the bone marrow.
The new authorisation for subcutaneous (SC) administration is based on data from a Phase III study which showed that the injection is as effective as intravenous (IV) delivery but with fewer side effects and greater convenience.
The MMY-3021 Phase III trial showed that pain and tingling in the extremities was observed in 38% of patients who received SC Velcade compared with 53% receiving IV.
Also, grade 3 or higher peripheral neuropathy events were reduced from 16% with IV to 6% with SC.
Adam Hill
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds
BioMed X and Servier launch Europe’s first XSeed Labs to advance AI-powered antibody design
BioMed X and Servier have announced the launch of Europe’s first XSeed Labs research project, …
