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European approvals for J&J cancer treatments

EC passes new Dacogen indications and backs subcutaneous Velcade

The European Commission has approved an extra indication for Johnson & Johnson's cancer drug Dacogen as well as a subcutaneous version of Velcade.

Marketed by J&J's pharma subsidiary Janssen, Dacogen (decitabine) is now available in Europe to treat adults over the age of 65 with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), while Velcade (bortezomib) can now be administered under the skin to treat the blood cancer multiple myeloma, instead of solely via an intravenous method.

The Dacogen approval follows a phase III trial comparing the drug to a patient's choice of either supportive care or low-dose cytarabine, made with advice from their physician.

According to J&J, the trial results demonstrated that patients taking Dacogen experienced a median overall survival of 7.7 months compared to 5.0 months for patients in the comparator arm.

The approval gives another option to patients in what is a notoriously difficult disease to treat, and adds to Dacogen's already approved indication for the treatment of myelodysplastic syndromes.

“Dacogen nicely complements our growing portfolio of therapies to treat haematologic malignancies, which is one of our key areas of focus in oncology,” said Dr Peter Lebowitz, oncology therapeutic area head of Janssen R&D.

The latest Velcade approval gives patients a “simpler, easier” way of taking the treatment, according to J&J, with the subcutaneous version demonstrated to be as effective as the less convenient intravenous method.

Professor Philippe Moreau, head of haematology at University Hospital Hôtel-Dieu, Nantes, France, and lead investigator on the phase III trial backing Velcade's subcutaneous approval, said the EC's decision would “impact hugely on the lives of patients” and that the drug will be important option in the treatment of multiple myeloma.

This was a view backed by Eric Low, chief executive of Myeloma UK, who described the approval as “fantastic news”.

He also urged fast uptake in the UK for the new method of treatment. “It is now important that clinical practice across the UK changes in a timely and effective manner to ensure myeloma patients benefit from subcutaneous Velcade as soon as possible,” he said.

The drug's benefits were described by Professor Graham Jackson, consultant haematologist at NCCC, Freeman Hospital, Newcastle Upon Tyne in the UK.

He said: "It offers the potential for reduced time in the clinic, making it more convenient for both healthcare professionals and patients alike.

"Subcutaneous administration could also be particularly beneficial for those patients with poor venous access, those with pre-existing peripheral neuropathy, or those at high risk of developing peripheral neuropathy.”

2nd October 2012

From: Sales, Regulatory



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