This treatment is meant for patients whose cancers express a protein called PD-L1 and that has not responded to platinum-based chemotherapy.
This approval allows Keytruda (pembrolizumab) or its under-the-skin injectable version Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) to be used in combination with the chemotherapy medicine paclitaxel, with or without targeted therapy with bevacizumab (Avastin).
The FDA has also approved a diagnostic test to identify patients with these epithelial cancers whose tumors produce sufficient levels of the PD-L1 protein to make them eligible for the new combination therapy.
Ovarian cancer usually starts in the ovaries or fallopian tubes and is a common and serious cancer in women.
Most patients receive platinum-based chemotherapy as their first treatment, but about 70%-80% see their cancer return, and roughly 25% develop platinum-resistant ovarian cancer within six months. This type of cancer is harder to treat and has a poor prognosis, and there are limited treatment options. In the U.S., primary peritoneal cancer is rare, with outcomes similar to those of advanced ovarian cancer.
Why Was It Approved?
The FDA’s approval was based on clinical studies that showed that adding Keytruda to chemotherapy delayed the worsening of the disease and helped people with PD-L1-positive ovarian, fallopian tube, or primary peritoneal tumors live longer.
What Do I Need to Know?
Keytruda is usually given through an intravenous line every three or six weeks based on the dose decided by your health care provider. The newer version, Keytruda Qlex, is given as a shot under the skin (in the thigh or belly area). You may continue treatment until your cancer gets worse or side effects become too serious, or for up to two years. Your health care provider will decide which version and schedule are best for you. Before starting treatment, your provider may test your tumor for the PD-L1 protein to help predict how well the medicine might work for you. Your health care provider may also check your liver, kidneys, and thyroid function before and during treatment and will monitor any side effects. Be sure to let your health care provider know if you have any kidney or liver conditions, lung or heart or thyroid problems, hormone issues, skin or allergic conditions, autoimmune conditions, or have had or are planning to have stem cell transplants. Also, tell them about all medicines, including any over-the-counter products, immune-suppressing medicines, vitamins, and herbal supplements, you take, as some may increase the risk of side effects. You should not take Keytruda or Keytruda Qlex if you’ve had a serious allergic reaction to any of their ingredients.
