MSD said it would voluntarily withdraw the FDA’s accelerated approval for Keytruda (pembrolizumab) as the third-line treatment for gastric cancer.

On Thursday, the company said it would withdraw the indication for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 and have received at least two prior therapies.

The prior therapies refer to fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted treatment.

MSD said it would pull Keytruda’s U.S. indication as the third-line treatment of gastric cancer.

The company’s decision came after the consultation with the FDA, following the FDA Oncologic Drugs Advisory Committee’s evaluation on April 29, MSD said.

Keytruda failed to show the overall survival benefit in a phase-3 trial, not meeting the post-marketing requirement.

Under the agreement with the FDA, MSD will start the retraction process in six months.

Patients with metastatic gastric cancer receiving Keytruda as the third-line treatment should discuss the treatment with their healthcare service provider, the MSD said.

MSD noted that the withdrawal would not affect Keytruda’s other indications.

Earlier, MSD obtained accelerated approval for Keytruda as a combination therapy with Herceptin (trastuzumab), fluoropyrimidine, and platinum-containing chemotherapy to treat locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Also, Keytruda won accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Keytruda is also indicated to treat adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

However, Keytruda’s safety and effectiveness in pediatric patients with TMB-H central nervous system cancers have not been verified.

“While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved, and we respect the FDA’s efforts to evaluate accelerated approvals continually,” said Scot Ebbinghaus, vice president of Merck (MSD) Research Laboratories.

Copyright © KBR Unauthorized reproduction, redistribution prohibited