Being investigated as intravesical instillation in non-muscle invasive bladder cancer.
Non-Muscle Invasive Bladder Cancer (NMIBC)
Cystoscopic appearance of tumors in the bladder.
Route of Administration
Intravesical Instillation (instilled directly into the bladder)
Mode of Action
Apaziquone is a bio-reductive agent activated by reductase enzymes, such as DT-diaphorase, expressed by bladder tumor cells, to form cytotoxic alkylating agents.
A) Bladder tumor before intravesical therapy.
Single Intravesical Instillation Studies:
Spectrum filed an NDA based on the previous Phase 3 studies. The FDA accepted the NDA and has given Spectrum a PDUFA date of December 11, 2016. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA.
The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous EOquin Phase 3 studies, as well as recommendations from the FDA.Spectrum conducted two multi-center, randomized, double-blind, placebo controlled, Phase 3 pivotal trials of single dose intravesical apaziquone to be instilled into the bladder in the immediate post-operative period after surgical resection of low-risk, non-muscle invasive bladder tumors. The primary endpoints were the rate of tumor recurrence at 2 years between apaziquone and placebo.
These two trials were analyzed individually and did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms.
According to the National Cancer Institute, bladder cancer is the fifth most common malignancy in the US with 74,000 new cases of bladder cancer expected in 2015, and currently over 500,000 patients living with the disease.
Approximately 70% of all patients newly diagnosed with bladder cancer have NMIBC. Urologists treat the disease predominantly by TURBT. In the U.S., there are approximately 300,000 TURBT procedures every year to treat bladder cancer. Because of the high recurrence rate, both professional urology associations and NCCN Guidelines recommend the instillation of a cytotoxic agent following TURBT for NMIBC, although in the U.S., there are no FDA-approved agents for this indication.
The global prevalence of bladder cancer is estimated at 2.7 million.
Risk factors for bladder cancer include smoking and exposure to certain industrial chemicals. Symptoms may include hematuria, painful or burning urination without evidence of a urinary tract infection, or abdominal pain. If detected early, bladder cancer is a managable disease.
The initial treatment of this cancer is complete surgical removal of the tumor (TURBT). However, bladder cancer is a highly recurrent disease with approximately 80% of patients recurring within 5 years, and a majority of these patients recur within 2 years.
Because bladder cancer patients have a high risk of recurrence, bladder cancer is the most expensive cancer to treat on a per patient lifetime basis. (Botteman et al., Pharmacoeconomics, 2003).
For additional information on bladder cancer, please refer to the following links:
The American Urological Association (AUA)
The Bladder Cancer Advisory Network (BCAN)
American Bladder Cancer Society (ABLCS) www.bladdercancersupport.org
National Cancer Institute
The links provided by Spectrum are for informational purposes only and are not meant to replace your physician's medical advice. Spectrum Pharmaceuticals, Inc. accepts no responsibility for the content of these sites. Spectrum does not control these sites, and the opinions, claims, or comments expressed on these sites should not be attributed to Spectrum. We recommend that you consult with your physician or other healthcare provider to obtain more information.