Endo Pharmaceuticals (Nasdaq: ENDP) today announced the availability of VALSTAR(TM) (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR is the only FDA-approved intravesical therapy for patients with Bacille Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks. VALSTAR represents a new treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.
"Patients with recurrent carcinoma in situ bladder tumors who fail traditional therapy have been significantly underserved due to the lack of available approved treatment alternatives, and VALSTAR will provide a well-tolerated treatment option for these patients," said Dave Holveck, president and chief executive officer of Endo Pharmaceuticals. "Our launch of VALSTAR also represents our initial offering in a long-term plan by Endo to deliver multiple therapies to improve and extend the lives of patients with different types of bladder cancer, as evidenced by our recent agreement with Bioniche."
VALSTAR, a sterile solution for intravesical instillation of valrubicin, is placed directly into the bladder through a catheter and is administered once a week for six weeks under the supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents.
In the pivotal clinical trial, VALSTAR was shown to induce a complete response in about one in five patients at six months following initiation of therapy, and 29 percent of patients derived a clinical benefit from VALSTAR treatment. It is important to note that if after VALSTAR treatment a patient does not have a complete response of CIS after three months, or if CIS recurs, surgical bladder removal must be reconsidered.