Spectrum to File NDA for Apaziquone Cancer Drug by Year’s End

Spectrum Pharmaceuticals is on track to file an NDA for its cancer drug apaziquone by the end of this year, following agreement with the FDA on a special protocol assessment for a Phase 3 clinical trial in patients with non-muscle invasive bladder cancer.

Under the special assessment, Spectrum will evaluate the intravesical use of apaziquone to treat patients with NMIBC immediately following transurethral resection of the bladder tumor, the company said last week. The protocol requires a 30- to 60-minute waiting period following resection of the tumor before instilling apaziquone, since the drug is known to be inactivated by blood.

Patients will be randomized to receive either one or two instillations of the drug or a placebo. Those receiving two instillations will receive the second dose about two weeks after surgery, minimizing the potential for inactivation due to bleeding.

The trial satisfies the FDA’s requirement of an additional Phase 3 study before Spectrum can submit an NDA for apaziquone.

Spectrum has conducted two Phase 3 studies of single intravesical instillation of apaziquone, involving a total of 1,615 patients. The results showed a statistically significant reduction in two-year recurrence rates. — Jonathon Shacat