Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK

fiercepharma | June 11, 2019

Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK
Tuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients. Regulators green-lighted the immuno-oncology star as monotherapy in patients whose tumors bear the biomarker PD-L1 and in combination with a commonly used chemo regimen in patients regardless of PD-L1 status. The regulatory wins follow a quick review from the agency, which bestowed its priority designation on Keytruda back in February. FDA staffers based the speed-up on data showing that that, when facing off against a standard-of-care regimen commonly referred to by the name “Extreme,” Keytruda could lower the risk of death by 22% in PD-L1 positive patients. And when paired with chemo, Keytruda slashed the risk of death by 23% regardless of patients’ PD-L1 status.

Spotlight

This compendium of facts and figures relating to the pharmaceutical industry and global health aims to provide a snapshot of the work this industry undertakes today. This publication examines the most recent data on pharmaceutical innovation and global health, access to medicines and healthcare systems, as well as the economic footprint of the pharmaceutical industry. The information further illustrates that the research-based pharmaceutical industry is one of the most innovative sectors in the world, which over the past century has played a unique role in developing new and improved medicines and vaccines to prevent and treat diseases.

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Spotlight

This compendium of facts and figures relating to the pharmaceutical industry and global health aims to provide a snapshot of the work this industry undertakes today. This publication examines the most recent data on pharmaceutical innovation and global health, access to medicines and healthcare systems, as well as the economic footprint of the pharmaceutical industry. The information further illustrates that the research-based pharmaceutical industry is one of the most innovative sectors in the world, which over the past century has played a unique role in developing new and improved medicines and vaccines to prevent and treat diseases.