BCIQ Profiles

Company Profile Report

PART 1

ODAC consequences

PART 2

ODAC Day 3

PART 2

ODAC Day 2

PART 4

ODAC Day 1

0429 ODAC Day Three
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Regulation

ODAC heeds Pazdur, recommends pulling Keytruda as third-line gastric cancer therapy

In hepatocellular carcinoma, ODAC votes favor Keytruda but not Opdivo

In hepatocellular carcinoma, ODAC votes favor Keytruda but not Opdivo.

Apr 30, 2021 | 1:06 AM GMT

FDA’s Oncologic Drugs Advisory Committee Thursday voted 6 to 2 to recommend withdrawal of accelerated approval for Merck’s Keytruda as third-line treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

The panel also voted on whether to retain accelerated approval for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) and Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) for second-line hepatocellular

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