- As expected, Spectrum Pharmaceuticals (NASDAQ:SPPI) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of QAPZOLA (apaziquone) for the immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
- The company met with the review team earlier this week to discuss the next steps and is evaluating a new smaller clinical trial that would replace the ongoing Phase 3 program that has stopped enrollment.
- In September, the FDA's advisory committee voted 14-0 against approval.
- Previously: Ad Comm review today for Spectrum Pharma's apaziquone (Sept. 14)