Another day and another approval for GlaxoSmithKline, this time in Europe and for the kidney cancer drug Votrient.
The European Commission has granted a conditional marketing authorisation for Votrient (pazopanib) for the first-line treatment of advanced renal cell carcinoma and for patients who have received prior cytokine therapy for advanced disease. The green light was expected given that the drug received a positive recommendation in February from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
GSK noted that as part of the conditional approval, it will provide data from ongoing clinical studies, Votrient, a once-daily, oral angiogenesis inhibitor which as well as starving the tumour of oxygen and essential nutrients also acts on the actual cause of the disease, is currently in a trial comparing the drug to Pfizer’s rival kidney cancer therapy Sutent (sunitinib).
Votrient, which was approved by the US Food and Drug Administration in October 2009, is also in Phase III trials for ovarian cancer and is being evaluated in Phase II studies for breast and non small-cell lung cancer, as well as for age-related macular degeneration. Analysts believe that the treatment could become a blockbuster.
The Votrient green light comes hours after GSK announced that the FDA has approved Jalyn, which is a single-capsule combination of the company’s Avodart (dutasteride) and tamsulosin, to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
