Roche will withdraw its cancer immunotherapy Tecentriq for a type of bladder cancer in the U.S., the company announced Tuesday, completing a sweep of the drug’s accelerated approvals that have not been confirmed through further study.
The Swiss drugmaker will no longer market the drug for any form of urothelial carcinoma, the first setting for which Tecentriq gained approval more than six years ago. Roche previously narrowed Tecentriq’s label to cover only patients who couldn’t take chemotherapy or whose tumors express a protein that Tecentriq targets, after clinical trial results called into question whether Tecentriq helped patients live longer.
The latest withdrawal was based on data from a study called IMVigor130, which tested Tecentriq with chemotherapy against chemotherapy alone in patients with bladder cancer that had spread, with the goal of showing Roche’s drug could help patients live longer. Patients given the Tecentriq-chemo combination lived a median of 16 months after treatment, compared with 13.4 months for those receiving just chemo, a difference that wasn’t statistically significant.
With this withdrawal, Roche will only sell Tecentriq in tumor types for which it has full Food and Drug Administration approval. Typically, full approvals are based on trial data showing a drug alone or in combination can help patients survive or delay cancer progression longer than a placebo or comparator treatment.
The company also withdrew Tecentriq’s approval for particularly difficult-to-treat form of breast cancer called “triple negative” after negative confirmatory data.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the U.S. FDA’s accelerated approval program, which brings innovative medicines to patients sooner,” Levi Garraway, Roche’s chief medical officer and head of global product development, said in a statement.
Tecentriq’s withdrawal in bladder cancer is a sign the FDA’s scrutiny of “dangling” accelerated approvals is having an effect. The regulatory pathway is relied on by developers of treatments of rare diseases, but has in recent years been used heavily to clear new cancer drugs quickly.
Immunotherapy rivals Merck & Co. and Bristol Myers Squibb have also withdrawn indications for their drugs Keytruda and Opdivo, in some cases driven by the FDA’s decision to call in outside advisers for consultation. Last week, GSK opted to pull its multiple myeloma drug Blenrep after a study failed to confirm its benefit.
Big drugmakers have been somewhat accommodating to FDA requests, but smaller ones have fought withdrawal. Covis Pharma is under pressure to withdraw its only product, an injection called Makena that aims to prevent preterm birth, and has battled with the agency to keep its accelerated approval as it gathers more data.