DCVax-L regulatory update

The U.K.'s Department of Health granted DCVax-L from Northwest Biotherapeutics promising innovative medicine (PIM) designation to treat all malignant gliomas, making it the first medicine to receive the designation. The designation is given to products that treat conditions that have no treatment options or have unsatisfactory treatment options based on quality, safety and efficacy data from Phase II or III testing. Products with a PIM designation will have access to joint parallel advice from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and NICE during development. DCVax-L -- an autologous dendritic cells treated ex vivo with glioblastoma tumor fragments -- is in Phase III testing to treat newly diagnosed glioblastoma multiforme (GBM), with data slated for 3Q15.

The designation is the first step of the U.K.'s Early Access to Medicines Scheme, which was launched in April. Under the scheme, if MHRA issues a positive scientific opinion in the second step, Northwest Biotherapeutics will be allowed to grant limited DCVax-L access free of charge to patients "when appropriate" until regulatory approval. Northwest Biotherapeutics has not disclosed an exact submission date for the second step, but the company says MHRA will deliver a scientific opinion within 90 days of the submission. The second step criteria expand the first step criteria by adding manufacturing standards. ...