Germany pushes faster route for new brain cancer drug

German health regulators, the toughest in Europe, have granted Northwest Biotherapeutics special permission to sell its experimental brain cancer drug, DCVax-L in the country, even though the small US  biotechnology company has not completed late-stage trial of the immunotherapy.

The special "hospital exemption" would allow Northwest to sell DCVax-L for five years, and seek renewed approval afterward, CEO Linda Powers says. It is only being tested in patients newly diagnosed with the most severe form of the disease, glioblastoma multiform , but will be available for all severities of brain cancer.

The European Union has encouraged member countries to create the hospital exemptions to foster use of breakthrough biotechnology drugs that have not yet won formal marketing approval.

Patients taking DCVax-L  along with standard care in in small informal trials lived 2.5 times longer than patients on standard treatment alone. DCVax-L is among an emerging crop of drugs that coaxes the body's immune system to track down and kill cancer cells. It harnesses dendritic cells, the immune system's master cells that give marching orders to its soldiers, including t-cells and b-cells, which make antibodies.

Treatment involves drawing a patient's immature dendritic cells from the blood and mingling these in a laboratory dish with ]antigens, or proteins, from brain tumour tissue of the patient obtained in surgery. When purified and injected back into the patient, DCVax-L could prompt t-cells and b-cells to leave lymph nodes and fan out through the body, seeking and attacking cells with target antigens.

Northwest Biotherapeutics is pushing ahead despite high-profile disappointments of dendritic cell-based therapies. Reuters