CONNAUGHT LABS' THERACYS (BCG, LIVE) WILL BE LAUNCHED
CONNAUGHT LABS' THERACYS (BCG, LIVE) WILL BE LAUNCHED in approximately three months, after scale-up of the product is completed. Theracys was approved for bladder carcinomain situ, a form of cancer found in 20-30% of the 45,000 cases of bladder cancer diagnosed in the U.S. annually, FDA said in a May 21 press release. The product, Bacillus Calmette Guerin Live (intravesical), involves a live but weakened bacteria that is administered at a high dosage directly into the bladder via a urethral catheter. The bacteria "cause an inflammatory reaction that eliminates many of the cancer cells," FDA said. The patient retains the product about two hours before urinating. The procedure is repeated once a week for six weeks and then monthly for six to 12 months. FDA noted that BCG Live "may be used alone or following surgical scraping to remove visible tumor growth." FDA's May 21 approval of TheraCys came about one month later than originally anticipated ("The Pink Sheet" April 23, "In Brief"). The agency explained that discussions about the product's labeling, specifically about whether or not to call it a vaccine, were the cause of the delay. A different formulation and concentration of BCG is licensed in the U.S. and elsewhere for use as a tuberculosis vaccine. However, TheraCys is not approved for use as a vaccine. The approval was based on a controlled study sponsored by the National Cancer Institute in which 74% of patients with CIS of the bladder responded to treatment compared to 42% receiving Adria's Adriamycin (doxorubicin). "Patients treated with BCG had a median time for recurrence of the cancer of four years," FDA said. Flu-like symptoms such as fever, chills and nausea, and discomfort related to inflammation of the bladder were the most common side effects following therapy, FDA noted. Labeling warns physicians "to watch for and treat any spread of BCG organism throughout the body, which has been associated with two deaths," the agency added. In a same-day release, Connaught Labs President David Williams commented: "We're very pleased that our first entry into cancer therapeutics and urology has such potential for [carcinoma in situ] patients."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth