The USA’s Antigenics has submitted its kidney cancer vaccine Oncophage for conditional approval in Europe.
The filing has been made through the European Medicines Agency’s conditional authorisation provision introduced in March 2006 which allows patients early access to new drugs that address an unmet medical need for which no satisfactory treatment option is available. In April, Russian regulators approved Oncophage (vitespen) and last month the US Food and Drug Administration gave Antigenics a licence to export the jab to that country.
Interestingly, Oncophage was turned down not so long ago by the FDA after top-line data from a Phase III study in renal cell carcinoma failed to show a benefit for the vaccine. However, Antigenics was able to show that the jab boosted recurrence-free survival by 45% in a subset of intermediate-risk patients – a group which crucially could be well-defined using kidney cancer staging criteria – and this was enough to get the Russian thumbs-up.
In addition to the findings from the Phase III trial, the European application includes data from 14 other completed clinical studies conducted with Oncophage. Antigenics believes the data package supports its bid to get approval for the vaccine as an adjuvant treatment in earlier-stage, localised renal cell carcinoma. If approved, it will be the first therapeutic cancer vaccine to receive a marketing licence from the EMEA.
The vaccine seems to fit the notion of personalised medicine to a tee as it is made from each patient’s own kidney cancer tissue at Antigenics’ facility in the USA. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with chemotherapy and radiation therapy.
The most recent data published by the International Agency for Research on Cancer estimated that there were 60,511 new cases of kidney cancer in the EU member countries in 2004, and about 29,453 people died. Despite earlier detection, patients with locally advanced disease face a poor prognosis, with a five-year survival rate of 50%.
