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Merck's sBLA for Keytruda in Lung Cancer Gets Extended Review

MerckMRK announced that the FDA has extended the review period of a supplemental Biologics License Application (sBLA) for its blockbuster drug, Keytruda, by three months. The sBLA is seeking approval of the PD-1 antibody as monotherapy for locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer ("NSCLC") in patients whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent).

As a result, the regulatory body will now announce its decision by Apr 11, 2019 instead of the previously anticipated date in January 2019. The FDA extended the review period as Merck submitted additional data and analyses, which was considered a major amendment to the sBLA.

The sBLA was filed based on overall survival ("OS") data from the phase III study - KEYNOTE-042 - which evaluated Keytruda in a patient population whose tumors express PD-L1 protein levels of 1 percent or greater.

Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent) based on data from the KEYNOTE-024 study.

If the OS data from KEYNOTE-042 study are approved to be included in Keytruda's label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market.

So far this year, Merck's shares have outperformed the industry , rising 30.6% compared with a 1.6% increase for the industry.

Data from the KEYNOTE-042 study showed that median OS was 16.7 months in the Keytruda arm versus 12.1 months in the chemotherapy arm in NSCLC patients with TPS of ≥1 percent. The median OS was 20 months and 17.7 months in patients with PD-L1 TPS ≥50 percent and TPS of ≥20 percent, respectively.

We remind investors that Keytruda is a key contributor to Merck's sales growth. The company is also focused on developing the drug in several cancer indications as well as in different treatment settings. In fact, the drug has received approval for label expansion in several cancer indications in 2018 including a difficult-to-treat metastatic squamous NSCLC in first-line setting.

Merck is also evaluating Keytruda in more than 850 clinical studies across a wide variety of cancers and treatment settings. Merck has collaborated with several companies including Amgen AMGN , Incyte INCY , Glaxo GSK and Pfizer separately for the evaluation of Keytruda in combination with other regimens.

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Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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