Roche withdraws Tecentriq for bladder cancer in US. How about Korea?

Roche has voluntarily withdrawn its anti-PD-L1 (programmed death-ligand 1) immunotherapy drug Tecentriq (ingredient name: atezolizumab) as a secondary treatment for bladder cancer in the U.S.

Roche has decided to withdraw Tecentriq as a second-line treatment for bladder cancer, causing some Korean experts to call for strengthening the country's conditional approval process for immunotherapy drugs.

As Korea currently reimburses the drug as a second-line bladder cancer treatment, regardless of the PD-L1 expression rate, industry insiders are keeping a close eye on how the company's decision will affect the drug's status in Korea.

Roche announced last Sunday that it would voluntarily withdraw its application for using Tecentriq as a secondary treatment for metastatic urinary tract epithelial cell carcinoma (bladder cancer).

The decision comes after the company received conditional approval from the U.S. Food and Drug Administration in 2016 for using Tecentriq to treat metastatic bladder cancer patients previously treated with platinum-based on its IMvigor 210 study.

Therefore, to confirm the indication, the company had to demonstrate the drug's clinical usefulness through its confirmatory clinical trial IMvigor 211 study. However, Tecentriq failed to improve the overall survival rate (OS), the study's primary endpoint.

Afterward, the FDA newly designated IMvigor 130 study as a new confirmatory clinical trial and was awaiting a company's final analysis. However, Roche decided to withdraw the indication, considering the rapidly changing bladder cancer secondary treatment market and the conditional approval principle.

Meanwhile, the United States' situation will likely affect the local bladder cancer treatment environment as well.

Tecentriq has received approval from the Ministry of Food and Drug Safety as both a first- and second-line treatment of advanced bladder cancer patients in Korea. The therapy has also been receiving health insurance benefits as a second-line treatment.

The voluntary withdrawal of the indication in the U.S. is highly likely to cause controversy over the drug's effectiveness. Considering that the drug is an expensive anticancer drug, there is a high possibility that a request for a re-evaluation on whether or not the medicine should be reimbursed.

However, there are also opinions from the industry experts who stress the need to observe Roche's actions in other countries.

Those experts have noted that as there are bladder cancer patients in Korea who are already receiving Tecentriq through reimbursement, they believe it necessary to observe whether Roche will withdraw the indications in other countries.

Local experts have also stressed that the application of reimbursement for conditionally licensed drugs in Korea should become stricter as conditionally approved immunotherapy drugs, such as Opdivio, Imfinzi, Keytruda, and Tecentriq, continue to withdraw their indications in the U.S.