Merck & Co., Inc. (NYSE:MRK) Seeks FDA Approval For Keytruda

Merck & Co., Inc. (NYSE:MRK)‘s Keytruda was shown in a study to reduce tumors in almost half of advanced lung cancer patients. Now, the company has filed for U.S. FDA approval of Keytruda as a treatment for patients suffering with NSCLC whose conditions have worsened despite initial treatment. The drug has already been approved for treatment of melanoma.

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The details

Keytruda is known as pembrolizumab and belongs to a new category of drug candidates formulated to help the immune system prevent cancer by blocking a protein named as “Programmed Death receptor.” It is popularly known as PD-1. Merck stated that its FDA lung cancer candidate treatment filing is for patients with both non-squamous and squamous NSCLC.

On Friday, Merck’s peer Bristol-Myers Squibb Co (NYSE:BMY) announced that a study of its PD-1 inhibitor known as Opdivo was concluded early after it was verified to work better than chemotherapy. The trial was conducted in previously treated patients suffering with non-squamous NSCLC. Bristol-Myers drug is already approved for treatment of uncommon squamous NSCLC and metastatic melanoma.

The scope

Lung cancer is one the major problems in the U.S. It kills almost 160,000 Americans annually. Therefore, the new drug candidate is considered as the biggest opportunity. The market sale of PD-1 drugs is expected to reach billions of dollars in next few years.

Merck enrolled 495 patients suffering with NSCLC for Phase I trial. The trial revealed that 45% of patients with PD-L1 high levels responded to Keytruda. For patients with PD-L1 levels in between 1% and 49%, the response rate was 16.5% whereas it came at 10.7% for patients with PD-L1 below 1%. The side-effects of Merck’s Keytruda included thyroid problems. The trial results were published in the ‘New England Journal of Medicine.’ They were also presented at a conference of the American Association for Cancer Research.

About the Author

Barry is a senior journalist at Us Markets Daily. He reports, shoots and edits many of his own stories by himself.

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