Antigenics gain approval for autologous vaccine in Russia

Implications: Oncophage is an autologous (or derived directly from a patient's own tumor cells) vaccine that may promote the generation of an effective anti-tumor immune response when re-injected into patients. Trials in melanoma and renal cell cancer failed to meet their primary endpoints and approval has not been forthcoming from the FDA.

Analysis: This is a fascinating development. Can new drug approval be obtained from alternative governmental agencies than the FDA or EMEA and through that approval gain access to patients (and vice-versa)? Will the revenue from this approval be significant for Antigenics? Will it lead to other non-standard country approvals for this drug? Will other companies follow suit? Will USA or EU patients, convinced of the drug's efficacy or desperate for any intervention, travel to a country where the treatment is approved, and pay cash to have the therapy?