FDA APPROVES PEMBROLIZUMAB FOR ADVANCED OR METASTATIC ESOPHAGEAL/GASTROESOPHAGEAL JUNCTION CANCER

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The United States Food and Drug Administration (FDA) has granted approval for Merck’s anti-programmed death ligand-1 (PD-L1) therapy pembrolizumab (Keytruda) to be used in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma. The approval applies specially to treatment of tumors with an epicenter 1 to 5 cm above the GEJ in patients who are not candidates for surgical resection or chemoradiation.

The basis for the approval was the phase III KEYNOTE-590 trial, which demonstrated improvement in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) with the addition of pembrolizumab to cisplatin plus fluorouracil chemotherapy.

Esophageal cancer is a disease characterized by formation of cancerous cells in the tissue lining the esophagus, while GEJ carcinoma is a rare form of esophageal cancer starting in the cells located in the GEJ. These diseases often do not cause symptoms until late in its progression and thus are usually diagnosed at a later stage, resulting in low survival rates. In unresectable cases, treatment options typically include chemotherapy, targeted therapy, and immunotherapy.

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