Northwest Biotherapeutics Inc has been given permission to sell DCVax-L, their experimental brain cancer treatment, in Germany according to a report by Reuters.
Though the company has not yet finished the late-stage trial of the immunotherapy, the U.S. based biotech will be allowed to sell the drug in Germany for five years with the opportunity to renew after. The company has been granted a special exemption to sell DCVaxL. This is the first time a product that was not available on the market previously has been granted such an exemption in Germany.
The news has caused the companies stock to surge, climbing 13 percent after the announcement according to Nasdaq.
According to Chief Executive Officer Linda Powers, Northwest Bio’s brain cancer treatment is reportedly being granted the exception because earlier clinical trials suggested that DCVaxL was more effective than other drugs on the market.
The drug has yet to be given formal marketing approval. However, if things go well that could change.
“If we meet the goals of the trial, we would plan to apply for marketing approval in Europe and the United States,” Powers said.
Northwest Bio plans to begin selling the drug within the next few months. Powers also said that she hopes the exception in Germany will encourage other countries to look at the drug in a positive light which will hopefully to lead to more similar exceptions.
The drug is only being tested on patients who are newly diagnosed with Glioblastoma multiforme, but the drug will be sold and used on patients with all types of brain cancer.
Northwest Bio Brain Cancer treatment Approved in Germany