Endo Pharmaceuticals, of Chadds Ford, Pa., has reintroduced Valstar (valrubicin) for the treatment of carcinoma in situ (CIS) of the urinary bladder that is refractory to treatment with Bacillus-Calmette-Guérin (BCG).


Valstar, which has been reformulated, represents another treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.

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Valstar, which is 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.


“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,” Endo president and CEO Dave Holveck said in a company press release.

In that same release, urologist Gary Steinberg, MD, observed: “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.”


Dr. Steinberg, Professor and Vice Chairman of Urology and Director of Urologic Oncology at the University of Chicago Medical Center, also noted: “Although valrubicin was previously available, it has never been an option for the thousands of people suffering today from this disease, and this reintroduction may bring new hope to many patients,” he added.


Valstar was approved by the FDA for CIS in 1998 and marketed by Anthra Pharmaceuticals, Inc. In 2002, Anthra voluntarily withdrew the medication from the U.S. market because of a formulation issue with an inactive component, according to Endo. On Feb. 27, 2009, Indevus Pharmaceuticals, Inc., the previous owner of Valstar, received FDA approval to re-introduce the drug after modifying the formulation.


On March 23, 2009, Endo acquired Indevus and began preparing to re-launch the drug, which is Endo’s first product launch in the urology and oncology therapy markets.