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FDA Breakthrough Therapy: Merck’s Keytruda Receives 2nd Designation For Advanced Non-Small Cell Lung Cancer

October 27, 2014

On October 27th, Merck announces that the FDA Breakthrough Therapy Designation (BTD) is given to Keytruda (Pembrolizumab) for the treatment of Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative Non-Small Cell Lung Cancer (NSCLC), where the disease progresses on or following platinum-based chemotherapy.

Keytruda is a “humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.”

The FDA BTD is based on data from the ongoing Phase Ib KEYNOYE-001 study. There are other clinical trials for Keytruda in advanced NSCLC:

•   Ongoing Phase II (KEYNOTE-010)

•   Ongoing Phase III (KEYNOTE-024)

•   Phase III planned to begin 4th quarter 2014 (KEYNOTE-042).

This is the 3rd FDA BTD for Merck and the 2nd FDA BTD for Keytruda (recently approved by the FDA for Melanoma):

 # Drug Name Indication
1 Keytruda (Pembrolizumab) Melanoma
2 Keytruda (Pembrolizumab) EGFR-Negative & ALK Rearrangement-Negative NSCLC




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “IMG Carlingford Lough 0617” by Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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