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FDA Approves Keytruda for Expanded First-Line Lung Cancer Treatment

On 5/10/17, the United States Food & Drug Administration (FDA) granted additional approved for Keytruda, a drug manufactured by Merck & Co., for the treatment of non-small cell lung cancer (NSCLC). Also used to treat blood cancer, melanoma, and head and neck cancers, Keytruda is now approved as a first-line treatment for previously untreated advanced lung cancer, in combination with chemotherapy.1

What Does This Approval Mean?

Keytruda is an immunotherapy treatment, belonging to a new class of cancer drugs known as PD-1 or PD-L1 inhibitor. These drugs help the immune system to find and attack cancerous tumors. This new approval makes Keytruda a treatment option for about 75% of all lung cancer patients.2

Prior to the new approval, Keytruda was indicated for3:

  • First-line treatment of metastatic NSCLC in patients with high levels of the PD-L1 protein
  • Secondary treatment of metastatic NSCLC with continued disease progression after chemotherapy

Under the new approval, Keytruda is also indicated for:

  • First-line treatment in combination with chemotherapy for metastatic nonsquamous NSCLC

Clinical Trial Data Show Promise

After a small clinical trial, Keytruda received accelerated FDA approval: “It was a small trial but the results were really quite striking,” said Roy Baynes, head of Global Clinical Development for Merck Research Labs.2 Although the FDA may require Merck to perform further research to study the benefits of the Keytruda/chemotherapy combination, the new drug combination is expected to have positive results for many patients.2,3

The FDA approved Keytruda for treatment in combination with Alimta (pemetrexed), a chemotherapy drug manufactured by Eli Lilly and Company.2 Keytruda is given through an intravenous (IV) infusion. When receiving Keytruda in combination with chemotherapy drugs, the patient should be given Keytruda first.

Some serious side effects can occur with Keytruda, including3:

Patients taking Keytruda should be monitored for immune-mediated adverse reactions, inflammation of the pituitary gland, thyroid disorders, type 1 diabetes, changes in kidney function, and infusion-related reactions. This medication may not be safe for pregnant or breastfeeding women.3

Click here for full prescribing and safety information. For help paying for Keytruda, including co-pay assistance, check out the Merck Access Program for Keytruda.

  1. Pharmaceutical Manufacturing. "FDA OKs Keytruda Combo for Lung Cancer." Pharmaceutical Manufacturing, 11 May 2017, Accessed 11 May 2017.
  2. Berkrot, Bill. "U.S. FDA approves Merck immunotherapy/chemo combo for lung cancer." Reuters, 11 May 2017, Accessed 11 May 2017.
  3. Merck. "Prescribing Information." United States Food & Drug Administration, May 2017, Accessed 11 May 2017.