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Merck voluntarily revokes Keytruda's accelerated approval for third-line treatment of gastric cancer in the U.S.

 Last Update: 2021-08-29
 Source: Internet
 Author: User

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On July 1, US Eastern time, Merck’s official website announced that it would voluntarily withdraw an indication previously approved by the FDA for Keytruda, specifically: for the treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) glands Cancer patients whose tumors express PD-L1 [combined positive score (CPS) ≥ 1]

The decision was made in consultation with the FDA after the Oncology Drug Advisory Committee evaluated Keytruda as a monotherapy for third-line gastric cancer indications on April 29, because Keytruda failed to meet its post-marketing proof of overall survival in a phase 3 study Period benefit requirements

The accelerated approval of Keytruda was first approved in September 2017.

Combined with trastuzumab and fluoropyrimidine/platinum-based chemotherapy, it is the first-line treatment for patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Merck’s clinical program for gastric cancer includes three first-line phase III trials: KEYNOTE-811, KEYNOTE-859 and LEAP-015, and the application of KEYNOTE-585 in neoadjuvant and adjuvant therapy

Reference source: Merck Provides Update on KEYTRUDA® (pembrolizumab) Indication in Third-Line Gastric Cancer in the US

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