Northwest Bio's DCVax Stuck 931 Days in U.K. Review
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- Northwest Biotherapeutics submitted a marketing application to the MHRA in late December 2023 for DCVax, its brain cancer treatment, under the U.K.'s expedited pathway for drugs addressing serious unmet medical needs.
- The expedited pathway set a 150-day review window, but 931 days (two years, six months, and 18 days) have elapsed without an approval decision — roughly 6.2 times the prescribed timeline.
- The MHRA has refused to explain the delay, telling inquirers — including STAT's reporter — that any update on DCVax's status must come from Northwest Bio itself.
- DCVax was filed as a treatment for brain cancer, a serious condition with limited therapeutic options that qualified the application for the U.K.'s fastest review track.
Why it matters: A drug placed on the U.K.'s expedited review track for serious unmet medical needs has now waited more than six times the 150-day window without a decision, and the regulator has refused to publicly account for the holdup. Brain cancer patients, Northwest Bio shareholders, and the credibility of the expedited pathway itself all depend on a process that neither the company nor the MHRA is currently explaining.
