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According to the U.
S.
Food and Drug Administration (FDA)’s accelerated approval pathway, the fate of the three cancer immunotherapies will be determined this week after confirming trials have failed.
The US FDA Oncology Drug Advisory Committee will review products approved under the breast, urinary tract tumors, gastric cancer and hepatocellular carcinoma pathways.
"We are committed to ensuring the integrity of the accelerated approval program, which aims to bring safe and effective drugs to patients with unmet medical needs as soon as possible.
In the past five months, these checkpoint inhibitor drugs have been withdrawn for other indications.
AstraZeneca and Roche have also withdrawn the drug's oncology indications after failing confirmation trials.
After AstraZeneca used Imfinizi for two weeks, Roche also withdrew Tecentriq's indication for bladder cancer.
In late December 2020, BMS withdrew Opdivo as an indication for the treatment of small cell lung cancer (SCLC), and patients have progressed after platinum-based chemotherapy and at least one other treatment.
The US FDA’s accelerated approval program allows patients with refractory cancers to use certain new therapies earlier.