Merck & Co. announced that it plans to voluntarily withdraw the US accelerated approval indication for Keytruda (pembrolizumab) monotherapy to treat third-line patients with recurrent, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1. The move comes a couple of months after an FDA panel voted 6 to 2 against maintaining the approval in this indication.
According to Merck, the decision was made in consultation with the FDA, with the withdrawal to be initiated in six months. "While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognise that the treatment landscape has evolved and we respect the FDA's efforts to continually evaluate accelerated approvals," remarked Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories.
Keytruda gained accelerated approval from the FDA in 2017 for patients with recurrent, locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumours express PD-L1, with disease progression on or after at least two prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy.
The authorisation was based on tumour response rate and durability of response data from a mid-stage trial. However, in the subsequent Phase III KEYNOTE-061 and KEYNOTE-062 trials, Keytruda failed to meet its post-marketing requirement of demonstrating an overall survival benefit.
Keytruda was granted an FDA accelerated approval this past May, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced, unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.
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