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FDA to review the accelerated approvals of Keytruda, Opdivo, and Tecentriq

Updated: Jun 27, 2023

The US FDA announced that it will hold a meeting of the Oncologic Drugs Advisory Committee on April 27-29 to review six indications accelerated approval.

The FDA commented that the drugs which received accelerated approval had not demonstrated clinical benefit in the confirmatory trials.

The drugs that are under review are Tecentriq, Keytruda, and Opdivo.





Tecentriq (atezolizumab): Tecentriq has received the accelerated approval for treating patients with advanced or metastatic triple-negative breast cancer whose tumors express PD-L1, treating advanced or metastatic urothelial carcinoma patients who are not candidates for cisplatin-containing chemotherapy



Keytruda (pembrolizumab): Keytruda has been indicated for treating advanced or metastatic urothelial carcinoma, advanced gastric or gastroesophageal carcinoma expressing PD-L1, treating patients suffering from hepatocellular carcinoma


Opdivo (nivolumab): Opdivo has been approved for hepatocellular carcinoma in sorafenib pre-treated patients




The FDA's Oncology Center of Excellence conducts an industry-wide evaluation of products that received accelerated approval but have not demonstrated the clinical benefit in the confirmatory trials.


Bristol Myers Squibb has voluntarily withdrawn Opdivo's approval for treating patients with metastatic small cell lung cancer in patients treated with chemotherapy and another therapy. Merck & Co., too, has planned to withdraw the same indication for Keytruda. Roche has withdrawn the advanced or metastatic urothelial carcinoma prior treated with chemotherapy indication for Tecentriq.




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