Roche pulls another FDA accelerated approval for cancer drug Tecentriq

A week after GSK sidelined its multiple myeloma drug Blenrep, following a confirmatory trial failure, Roche has done the same for a key indication of its blockbuster cancer drug Tecentriq.

Following consultation with the FDA, Roche has withdrawn Tecentriq's use as a first-line treatment for a form of advanced bladder cancer. The move, like that for Blenrep, is another in a growing list of accelerated approvals that have been overturned because of doubts raised in post-approval confirmatory trials.

Final analysis of the Imvigor130 trial, which tested Tecentriq plus platinum-based chemotherapy against chemotherapy alone failed to “cross the statistical threshold for overall survival,” Genentech’s chief medical officer, Levi Garraway, M.D., Ph.D., said in a press release.

The trial was designed to convert the accelerated approval to a full approval and represents another setback for Tecentriq. The withdrawal nixes the use of the drug for locally advanced or metastatic bladder cancer patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 

Last August, after the failure of a triple-negative breast cancer confirmatory trial of Tecentriq in combination with Bristol Myers Squib’s Abraxane, Roche pulled use of the product in that indication.

That move came five months after Roche kissed another accelerated approval for Tecentriq goodbye, that for patients with metastatic urothelial carcinoma previously treated with chemotherapy.

And this July, brought another Tecentriq trial flop—though not a confirmatory study—in post-surgery kidney cancer.

Sales of Tecentriq—which was first approved in the U.S. in 2016—reached just over $3 billion in 2021 but have leveled off this year.

Not all the recent news on Tecentriq has been negative, however. Last October, the FDA signed off on use of the immunotherapy for non-small cell lung cancer patients after tumor surgery.

“We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” Garraway said in the release.