July 28, 2021

The U.S. FDA has approved two new indications for Merck’s Keytruda (pembrolizumab), one for endometrial carcinoma and one for triple negative breast cancer (TNBC).

The first new indication, granted on July 22, 2021, is for Keytruda’s use in combination with Lenvima® (lenvatinib – Eisai), also newly approved for this indication, to treat advanced endometrial carcinoma in certain patients who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. The approval is based on a clinical trial in which Keytruda plus Lenvima reduced the risk of death by 32% and the risk of disease progression or death by 40% compared to chemotherapy.

On July 27, 2021, Keytruda also received FDA approval to treat high-risk, early-stage TNBC when used in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent adjuvant therapy following surgery. In a clinical trial, Keytruda plus chemotherapy and then used a single-agent adjuvant treatment reduced the risk of disease progression by 37% compared to chemotherapy alone.

Advanced endometrial carcinoma is a difficult-to-treat cancer with just a 17% five-year survival rate when curative surgery is not an option. Although early-stage TNBC has a high five-year survival rate, it also has a high recurrence rate and has fewer treatment options than other types of breast cancer.

Recommended dosing with Keytruda for both indications is 200mg administered by intravenous (IV) infusion once every three weeks or 400mg via IV infusion once every six weeks. For advanced endometrial carcinoma, when Keytruda is used with Lenvima, the combination therapy should continue for up to 24 months or until disease progression or unacceptable toxicity occur. For TNBC when used in combination with chemotherapy and then as single-agent adjuvant therapy, Keytruda should be used with chemotherapy for 24 weeks or until disease progression or toxicity occur, followed by adjuvant treatment with Keytruda for up to 27 weeks or until disease progression or toxicity occur.

First FDA approved in 2014, Keytruda now holds 30 indications to treat cancer.

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