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Regulatory News | 18 November 2016 | By Zachary Brennan
Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).
Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government to step in and posted the letter from Sanofi informing physicians of the decision.
Sanofi said production will cease at the Canadian manufacturing facility where the treatment is made in mid-2017 and production elsewhere will not resume.
In 2012, the Canadian facility received a warning letter from FDA, saying, among other violations, that “sterility for all lots of TheraCys, BCG Live (Intravesical) (BCG-IT) manufactured in Building (b)(4) since the last successful BCG Sterility Test Method Validation in 2000 cannot be assured.”
And when the facility closed down in 2012, many patients either missed doses or received inferior drugs in place of the BCG, according to another Davies article here.
That same Toronto facility later said in October 2015 that following these mold and other problems, Health Canada would allow it to resume production of the drugs later in 2015, though it was still awaiting an inspection by FDA.
Sanofi said in its letter this week that no other companies would take on the manufacture of the product and "the product will not be re-launched in the US."
Separately on Thursday, Spectrum Pharmaceuticals said FDA had rejected its NMIBC treatment, apaziquone. “Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped,” the company said in a SEC filing.
Telesta Therapeutics also received a complete response letter for its NMIBC treatment from FDA in February, saying an additional Phase 3 clinical trial for would be necessary.
Following those rejections, FDA on Friday issued a 12-page draft guidance to assist pharmaceutical and biotech sponsors trying to develop drugs and biologics to treat patients with this high-risk form of bladder cancer.
“The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality,” FDA says.
In terms of developing the new treatments, the draft reads: “The preferred trial design for demonstrating efficacy of drugs developed to treat NMIBC is a randomized, controlled trial with a time-to-event endpoint of recurrence free survival. Single-arm trials are appropriate in clinical settings for which a randomized, controlled trial is either unethical or not feasible. Therefore, single-arm trials of patients with BCG-unresponsive carcinoma in situ with or without papillary disease using an endpoint of complete response rate (and duration) may be appropriate.”
Federal Register Notice
Tags: bladder cancer, NMIBC, Sanofi, drug shortage