FDA Approves Merck & Co., Inc. (NYSE:MRK) Keytruda For NSCLC

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The US Food and Drug Administration (FDA) has recently approved the anti-programmed-death-receptor-1 (anti-PD-1) therapy of Merck & Co., Inc. (NYSE:MRK), Keytruda (pembrolizumab), for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients.

US FDA Approval

With the approval, Keytruda is presently the only anti-PD-1 therapy used as a first-line treatment for the condition. Keytruda has been approved for administration of 200 mg every three weeks until disease progression or for a maximum of 24 months among patients without disease progression.

The US FDA has also approved a labeling update, allowing the inclusion of KEYNOTE-010 data in the second-line or greater treatment setting for metastatic NSCLC patients with disease progression on or following platinum-containing chemotherapy.

According to Dr. Roger Perlmutter, Merck Research Laboratories President, Keytruda can significantly improve the survival rate of metastatic NSCLC patients compared to traditional treatments such as chemotherapy. Consequently, the approval of Keytruda can potentially enhance the treatment options available for the condition and even the lifestyles of metastatic NSCLC patients.

“With this new indication, KEYTRUDA can now be a first treatment option instead of chemotherapy for patients with metastatic non-small cell lung cancer whose tumors express high levels of PD-L1,” noted Roy Herbst, M.D., Ph.D., Yale Cancer Center Professor of Medicine, of the recent US FDA approval.

The approval of Keytruda is strongly backed by the data from KEYNOTE-024, a randomized, open-label, phase 3 clinical trial evaluating the monotherapy against standard of care (SOC) platinum-containing chemotherapy for the treatment of metastatic NSCLC patients. It has enrolled subjects who have not previously received systemic chemotherapy treatment.

Keytruda Safe?

While Keytruda has been proven effective for its approved indication, it is also associated with some adverse reactions. These include colitis, endocrinopathies, hepatitis, nephritis, and pneumonitis. Keytruda administration must be discontinued depending on the severity of the occurrences of these side effects.

The drug can also cause serious infusion-related reactions. Should these occur, Keytruda administration must be discontinued permanently. As for those who are pregnant and taking Keytruda, the drug can cause fetal harm as well.

On Tuesday, Merck has closed at $61.95, up by 1.98%.