Intravesical therapy available for aggressive bladder cancer

September 24, 2009

Endo Pharmaceuticals has announced the reintroduction of valrubicin (VALSTAR) intravesical therapy for the treatment of Bacillus Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.

Endo Pharmaceuticals has announced the reintroduction of valrubicin (VALSTAR) intravesical therapy for the treatment of Bacillus Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.

Valrubicin, a sterile solution for intravesical instillation, is placed directly into the bladder through a catheter and is administered once a week for 6 weeks. In a clinical trial, valrubicin was shown to induce a complete response in one in five patients at 6 months following initiation of therapy, and 29% of patients derived a clinical benefit from treatment. The company notes that, if after treatment a patient does not have a complete response of CIS after 3 months, or if CIS recurs, surgical bladder removal must be reconsidered.

"Patients who have failed multiple courses of BCG have few to no remaining treatment alternatives, in part because many patients cannot undergo surgical bladder removal due to comorbid medical conditions, and the procedure may be associated with significant risk of complications and alteration of lifestyle and body image," said Gary Steinberg, MD, of University of Chicago Medical Center. "Although valrubicin was previously available, it has never been an option for the thousands of people suffering today from this disease, and its reintroduction may bring new hope to many patients."