FDA Approves Keytruda (Pembrolizumab) for Head and Neck Cancer


The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as a first-line treatment for people with advanced head and neck cancer. The approval is for people with head and neck squamous cell carcinoma that has spread or that has come back and can’t be removed through surgery. In this setting, Keytruda can be used along with chemotherapy, or it can be used alone if the cancer cells have a certain level of the PD-L1 protein.

Keytruda is a type of immunotherapy drug called an immune checkpoint inhibitor. The PD-L1 protein on the surface of some cancer cells can help them avoid being found and destroyed by the body’s immune system. Drugs that block the PD-L1 protein, or the corresponding PD-1 protein on immune cells (such as Keytruda), can help the immune system recognize the cancer cells and attack them. Keytruda is already on the market to treat several other cancer types.

The FDA based the new approval on a trial of 882 people with advanced head and neck squamous cell carcinoma. It compared Keytruda with or without chemotherapy (cisplatin or carboplatin plus 5-FU) to a combination of cisplatin or carboplatin plus 5-FU and Erbitux (cetuximab). Results showed an overall survival of 13 months for the Keytruda-plus-chemo group compared with 10.7 months for the chemo-plus-Erbitux group. Among patients whose tumors tested positive for the PD-L1 protein, those with higher levels had higher response rates using Keytruda alone than those with lower levels.

Keytruda is given as an infusion into a vein, typically once every three weeks. The most common side effects are fatigue, pain, decreased appetite, itching, rash, diarrhea, nausea, fever, cough, shortness of breath, and constipation. Keytruda also has the potential to cause the immune system to attack other parts of the body, which can lead to severe side effects in some people.

Keytruda is marketed by Merck & Co., Inc.



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