An experimental brain cancer drug still in its late clinical stages, developed by Northwest Biotherapeutics Inc., has been given the green light in Germany.
This special "hospital exemption" would let Northwest sell DCVax-L for the next five years, then would be required to seek renewed approval afterward, Northwest Biotherapeutics Chief Executive Officer Linda Powers said in an interview. She, on behalf of Northwest, expresses their excitement for this milestone in cancer treatment.
"Patients will now have a promising new treatment option, and the Company will have an invaluable opportunity to begin practicing now for commercial operations in the future," Powers said in a news release.
Even though this drug is only being tested in patients newly diagnosed with Glioblastoma multiforme (GBM), the most severe type of brain cancer, Northwest is allowed to sell DCVax-L to patients in hospital or outpatient clinics with all severities of brain cancer. Powers estimated that at least 3,000 cases of GBM are seen in Germany each year.
DCVax-L is the first product of its kind to receive Hospital Exemption approval from the German regulators. For example, it is the first immunotherapy drug to be offered, and also the first product available that has never previously been on the market commercially.
The treatment consists of an individual patient's immature dendritic cells being drawn from the blood, purified and injected back into their bloodstream where DCVax-L prompts the body to destroy tumor cells. DCVax-L can only be used after patients receive the standard care for brain cancer, which consists of surgery, radiation and treatment with Merck & Co Inc's Temodar chemotherapy.
"When you add Temodar to surgery and radiation you get an additional 2.5 months of survival," Powers said in a Reuters report, allowing the average patient to survive 14.5 months.
The average patient taking DCVax-L plus standard treatment in Phase I and II of the study survived three years, without additional serious side effects.
The company has not yet requested or received formal marketing approval for its product, but expects to after their expected completion of late-stage trials in 2015.
"If we meet the goals of the trial, we would plan to apply for marketing approval in Europe and the United States," Powers said.
