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Merck Files FDA Application for Keytruda/Chemotherapy Combo for Lung Cancer



This is the first time an application has been filed for regulatory approval for the company’s anti-PD-1 therapy to be used together with another cancer treatment.

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January 13, 2017 | by Sarah Hand, M.Sc.

This week, Merck submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for a drug combining Keytruda and chemotherapy for the treatment of metastatic or advanced non-squamous non-small cell lung cancer (NSCLC). This is the first time an application has been filed for regulatory approval for the company’s anti-PD-1 therapy to be used together with another cancer treatment.

The FDA granted Merck Priority Review, which should expedite the approval process. Merck is hoping that the Keytruda/chemotherapy combo is approved for the first-line treatment of lung cancer patients, regardless of whether they overexpress the immune checkpoint protein, PD-L1.

“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “Keytruda, in combination with chemotherapy, has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”

Keytruda is currently approved as a monotherapy for the first-line treatment of metastatic NSCLC in patients who show tumor expression of PD-L1. To be eligible for treatment with Keytruda, these patients must also have previously received platinum-containing chemotherapy and experienced disease progression.

About 85 percent of all cases of lung cancer are diagnosed as NSCLC, making it the most common form of the disease. Keytruda is an immunotherapy drug designed to strengthen the body’s immune system to both detect and destroy tumor cells. Along with its indication for lung cancer, Keytruda is also approved to treat melanoma, as well as head and neck squamous cell carcinoma.

Keywords: FDA, Lung Cancer, Immunotherapy


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