FDA Approves VALSTAR For Bladder Cancer Therapy
Indevus Pharmaceuticals has received an approvable letter from FDA for VALSTAR.
VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder.
VALSTAR was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus solved the impurity issue and submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007. The FDA approvable letter was in response to this chemistry supplement.
In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.
"VALSTAR offers an effective alternative for bladder cancer patients who have failed BCG therapy and are not candidates for immediate cystectomy," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process related investigations. We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re- introduction."
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
In clinical trials, when provided after transurethral resection, VALSTAR patients had a median 21 months to documented recurrence of disease.
VALSTAR has been shown to induce complete response in only about 1 in 5 patients with BCG-refractory CIS. It is important to note that delaying cystectomy could lead to development of metastatic bladder cancer.