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July 2, 2021Merck Announces Plan to Withdraw Keytruda's Monotherapy Indication for PD-L1 Positive Gastric and GEJ Cancer
July 1, 2021 – Merck will voluntarily withdraw an indication for Keytruda® (pembrolizumab) to be used as a third-line monotherapy for patients who have gastric or gastroesophageal junction (GEJ) cancer that tests positive for PD-L1. The indication was granted by the FDA under accelerated approval, with continued approval contingent on confirmation of clinical benefit in confirmatory trials.
Merck’s decision follows an April 2021 recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC). ODAC members voted 6-2 in favor of withdrawing the indication’s approval. In two confirmatory trials, Keytruda failed to demonstrate an overall survival benefit as a monotherapy for PD- L1 positive gastric or GEJ cancer. Merck plans to begin the withdrawal in six months.
Withdrawal of the indication does not affect Keytruda’s other FDA-approved indications – including an indication to treat gastric and GEJ cancers when used in combination with Herceptin® (trastuzumab – Roche) and chemotherapy. It also does not prevent doctors from prescribing the medication off label as a monotherapy for gastric or GEJ cancers.