The FDA's Oncologic Drugs Advisory Committee (ODAC) voted on Wednesday that accelerated approvals granted a few years ago to Roche's Tecentriq (atezolizumab) and Merck & Co.'s Keytruda (pembrolizumab) in first-line urothelial carcinoma (UC) should be maintained. The ODAC votes came on the second day of a three-day review into US accelerated approvals for checkpoint blockers whose benefits have yet to be established in confirmatory trials.
Tecentriq was awarded accelerated approval by the FDA in 2017 for use in patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy. The decision was based on tumour response rate and duration of response data from the IMvigor210 study. However, while Roche's anti-PD-L1 immunotherapy significantly reduced the risk of disease worsening or death compared to chemotherapy alone in the confirmatory IMvigor130 trial, an interim analysis showed no statistical benefit in terms of overall survival (OS).
On Wednesday, the FDA panel voted 10 to 1 that the accelerated approval for Tecentriq in this indication should not be revoked pending final OS results from IMvigor130. Levi Garraway, head of global product development at Roche, said "having now received positive ODAC recommendations in both bladder cancer and triple-negative breast cancer, we will continue to work with the FDA on next steps for Tecentriq in these indications."
Meanwhile, the FDA panel also looked at Keytruda's accelerated approval for first-line patients with cisplatin-ineligible and carboplatin-ineligible locally advanced or metastatic UC, and voted to uphold that approval by a margin of 5 to 3, pending conduct or completion of an additional trial or trials. The 2017 approval was based on objective response rate results from the Phase II KEYNOTE-052 study, although the subsequent Phase III KEYNOTE-361 trial failed on the dual primary endpoints of OS and progression-free survival, compared with standard chemotherapy alone.
On Thursday, the final day of the ODAC meeting, the panel will review Keytruda's accelerated approvals in gastric cancer and hepatocellular carcinoma, as well as the accelerated approval for Bristol Myers Squibb's Opdivo (nivolumab) in liver cancer as well.
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