Antigenics Inc announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer).
Antigenics will evaluate its options, including an appeal of this decision, after the CHMP has formally adopted an opinion at the November 2009 plenary meeting. The patient population for which approval is being sought represents a major unmet medical need. There are no approved drugs in Europe or the United States for the post-surgical treatment of adjuvant kidney cancer, a disease characterized by a high risk of recurrence. Antigenics believes clinically relevant benefits were demonstrated with Oncophage in both recurrence-free survival and overall survival endpoints and that this benefit has persisted for nearly five years.
“With the considerable support of the urology and oncology communities, we will continue to evaluate our options for making Oncophage available to kidney cancer patients in the EU,” said Garo Armen, chairman and CEO of Antigenics.
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.