Label Expansion Expected to Boost Keytruda’s 2017 Revenue


Dec. 4 2020, Updated 10:52 a.m. ET

Label expansion

On October 24, 2016, the FDA approved Merck & Co’s (MRK) Keytruda as a second-line therapy for patients suffering from non-small cell lung cancer (or NSCLC).

When tested using companion diagnostic test, more than 1% of the tumor cells in these patients expressed the PD-L1 antigen. This approval was based on results from the KEYNOTE-010 study, which demonstrated a superior clinical profile for Keytruda compared to chemotherapy agents as second-line NSCLC therapies.

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On October 24, 2016, FDA also approved Keytruda as a first- line NSCLC therapy for patients with 50% or more tumor cells that express the PD-L1 antigen. This approval was based on results from the KEYNOTE-024 trial, in which Keytruda demonstrated a superior overall response rate and reduced risk of death in NSCLC patients compared to the platinum doublet therapy.

These developments have strengthened Keytruda’s position in the lung cancer segment. To know more about Keytruda and its lung cancer indications, read Will Keytruda’s Position Strengthen in the Lung Cancer Market?

If Keytruda continues to expand its addressable market in the lung cancer segment, it could have a positive impact on Merck’s share prices as well as the share price of the Vanguard Total Stock Market ETF (VTI). Merck makes up ~0.75% of VTI’s total portfolio holdings.

New indications

On November 28, 2016, Merck announced its submission of an application to the FDA seeking approval for Keytruda as a therapy for patients who have received prior treatment and are suffering from advanced microsatellite instability-high (or MSI-H) cancer. The company expects an FDA decision by the Prescription Drug User Fee Act date of March 8, 2017.

On February 3, 2017, the FDA accepted for review Merck’s application seeking approval for Keytruda in first-line and second-line settings for advanced urothelial cancer. The Prescription Drug User Fee Act date for this application has been set at June 14, 2017.

Merck has also received breakthrough therapy designation for Keytruda as a treatment option for primary mediastinal B-cell lymphoma. The drug is also awaiting the FDA’s decision on its application for the indication of relapsed or refractory classical Hodgkin’s lymphoma. The FDA is expected to declare its decision by the Prescription Drug User Fee date of March 15, 2017.

With Keytruda, Merck poses a tough competition to oncology players such as Bristol-Myers Squibb (BMY), Pfizer (PFE), and Eli Lilly (LLY).


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