Antigenics Inc announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma (kidney cancer) under the conditional authorization provision. Currently, there are no EMEA-approved drug therapies for this patient population.
"The creation of the EMEA's conditional approval regulation provides an important mechanism for allowing patients and physicians potentially earlier access to products that fulfil an unmet medical need for serious or life-threatening diseases," said Garo H Armen, chairman and chief executive officer of Antigenics. "This application represents a major achievement in the development of Oncophage, and if approved, will be the first therapeutic cancer vaccine to receive a marketing license from the European agency."
Oncophage received European orphan drug status in 2005, which offers the potential for 10 years of market exclusivity and would allow authorization to market Oncophage in all 27 European Union (EU) member states and non-member states including Norway and Iceland. Orphan drug status also permits the company to request fee reductions for the MAA under the centralized procedure.
In advance of the MAA submission, meetings with EMEA representatives, including the rapporteur countries, were convened to discuss the results from the international, multicenter, Phase 3 kidney cancer trial as well as the company's intention to file under the conditional approval provision. The review of the application will be coordinated by the EMEA, with the UK authorities acting as rapporteur for the application and the French authorities as co-rapporteur.
In addition to the findings from the phase-3 kidney cancer trial, which is the largest trial completed to date in the adjuvant setting, the application included data from 14 other completed clinical studies conducted with Oncophage. Antigenics believes the results from the phase-3 kidney cancer study will support a European indication for the use of Oncophage as an adjuvant treatment in earlier-stage, localized renal cell carcinoma. In accordance with the trial, this patient population is characterized by the presence of stage-I or II disease - as defined by the American Joint Committee on Cancer (AJCC) - and high Fuhrman grade.
Conditional approval is the EU provision introduced in March 2006 allowing patients early access to new drugs that address an unmet medical need for which no satisfactory treatment option is readily available. Antigenics will likely need to conduct further clinical studies of Oncophage as part of a series of post-approval obligations. A conditional marketing authorization is valid for one year and may be renewed annually.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. Antigenics continues to explore other major geographical territories for regulatory approval of Oncophage.
Derived from each individual's tumour, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint.
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.