In 2016, Sanofi announced that they will stop the production of their BCG therapy called ImmuCyst by 2019, following manufacturing issues that created drug shortage since 2012.
The shortages of Sanofi's bladder cancer drug date to 2012 when the FDA slammed the plant over sterility issues after it had been flooded and developed a mold problem. The French drug agency ANSM has therefore restricted the indications of BCG therapy to only the high risk group and suspended the indication of the maintenance treatment. High-risk patients treated between January 2014 and December 2016 were therefore "sub-treated" with regards to recommendations for maintenance treatment for at least one year, and intermediate-risk patients were treated with mitomycin.
The prognostic and economic impact of this production crisis was evaluated by a retrospective study comparing patients treated for intermediate and high risk urothelial carcinoma. The primary endpoint was tumor recurrence with or without progression; secondary endpoint was the impact of recurrence on the average cost per patient.
The authors found that the relative risk of recurrence during the shortage period was 2.6 (3.36 intermediate risks and 1.87 high risk); the relative risk of cystectomy was 4.52. Overall, the average additional cost per patient was increased by 196%. Despite the measures taken to compensate for the shortage, it had a significant medical and economic impact, which resulted in an increased rate of BC recurrence with a significant risk of cystectomy.
This issue needs to be addressed at global level as it is a world wide health challenge that cannot be fixed at a national level. It raised the questions of drug manufacturing responsibility and the responsibility to give access to safe and effective recommended treatment for cancer.
Speaker: Marc Colombel, Professor Edouard Herriot Hospital, Lyon, France
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at The 15th Meeting of the EAU Section of Oncological Urology ESOU18 - January 26-28, 2018 - Amsterdam, The Netherlands
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