Regulators in Europe have given the green light to Novartis’ Afinitor for advanced kidney cancer, Genzyme’s cancer drug Mozobil and Otsuka Pharmaceutical Co’s hyponatraemia therapy Samsca.

First up, the Commission approved Novartis’ Afinitor (everolimus), a once-daily, oral treatment that inhibits the mTOR protein, for patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapies. The approval was based on a Phase III trial which showed that the drug more than doubled the average time without tumour growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and reduced the risk of disease progression or death by 67%.

The drug, which was approved by the US Food and Drug Administration in March, is also in development for lymphoma, breast, gastric, lung and other cancers, as well as tuberous sclerosis.

The EC has also granted marketing authorisation for Genzyme’s injectable Mozobil (plerixafor) for patients with lymphoma and multiple myeloma who require an autologous stem cell transplant. Specifically it is indicated in combination with granulocyte-colony stimulating factor (G-CSF).

Mozobil could ‘transform’ stem cell transplants
More than 1,000 patients in Europe have already received Mozobil through compassionate use programmes that began about one year ago for patients who failed to mobilise enough cells for transplantation using the current standards of care, or were predicted to fail based on clinical laboratory indicators.

Genzyme quoted Mohamad Mohty of the University Hospital in Nantes, France, as saying that “Mozobil has the potential to transform the field of stem cell transplantation”.

Tolvaptan OK
The Commission has also given the nod to Otsuka’s oral once-daily Samsca (tolvaptan), a selective V2-vasopressin receptor antagonist, for the treatment of hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion in adults. It is the first such treatment to become available in Europe.

Chris Thompson, professor of endocrinology at Beaumont Hospital, Dublin, noted that “hyponatraemic patients are vulnerable to a vast array of symptoms and complications” and the treatments available “have had limited efficacy or significant tolerability issues”. He added that “clinicians will be aware of the excellent safety record and efficacy of tolvaptan” and “will welcome the availability of a therapeutic agent which specifically treats the underlying cause of hyponatraemia.”