Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval

Sanofi Pasteur has announced the completion of the manufacture of TheraCys, an important drug against bladder cancer, and shortages are expected, while the Food and Drug Administration (FDA) on Friday issued draft guidelines to help develop new treatments for non-invasive nonmuscular cancer NMIBC ).
Benjamin Davies, MD, associate professor of urology at the University of Pittsburgh School of Medicine, wrote in Forbes on Thursday, called on the government to step in and posted Sanofi's letter informing doctors of the decision.

Sanofi said production would cease at the Canadian manufacturing facility in mid-2017 and production will not resume.

In 2012, the Canadian facility received a warning letter from the FDA stating that "sterility for all batches of TheraCys, BCG Live (Intravesical) (BCG-IT) manufactured in the building (B) Method Validation in 2000 can not be insured. "

And when the facility closed in 2012, many patients either missed doses or received lower medications in place of BCG, according to another Davies article here.

The same Toronto facility later stated in October 2015 as a result of these molds and other problems Health Canada would allow it to resume production of drugs later in 2015, The FDA.

Sanofi said in his letter this week that no other company would take on the manufacture of the product and "the product will not be relaunched in the United States."

Rejection and draft guidance from the FDA

Separately on Thursday, Spectrum Pharmaceuticals said the FDA had rejected its NMIBC treatment, Apaziquone. "Based on the discussions, the Company is evaluating a new, more modest study that would replace the ongoing Phase 3 program in which enrollments were stopped," the company said in a fil filing.

Telesta Therapeutics also received a full response letter for its FDA NMIBC treatment in February, saying an additional Phase 3 clinical trial would be required.

Following these refusals, the FDA released Friday to 12-page draft guidelines to help pharmaceutical and biotech promoters try to develop drugs and biologics to treat patients with this form of high-risk bladder cancer.

"The alternative is radical cystectomy, the surgical procedure with significant morbidity and mortality," says the FDA.

"The preferred trial design to demonstrate the efficacy of drugs developed to treat NMIBC is a randomized, controlled trial with a survival time without recurrence. (BCG) in situ, with or without papillary using a complete end-of-response rate criterion (and duration) may be appropriate.