FDA Approves Keytruda® for Adult and Pediatric Patients with Classical Hodgkin
It was announced today that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma.
Hodgkin’s lymphoma is a cancer of the lymph system. It typically begins in the lymph nodes in one region of the body and then spreads throughout the lymph system. Hodgkin’s lymphoma is one of the more curable cancers with effective treatments available at several stages of disease. Some patients with relapsed or refractory HL may also be cured with high doses of chemotherapy and stem cell transplant. For patients that fail stem cell transplant additional treatment options are limited.
Keytruda® is a monoclonal antibody that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein used by cancer cells called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer. Keytruda® is approved for the treatment of certain types of metastatic melanoma and head and neck cancer.
The approval is based on data in 210 patients from the KEYNOTE-087 trial, which demonstrated an overall response rate with of 69 percent with a complete remission rate of 22 percent and a partial remission rate of 47 percent. The median follow-up time was 9.4 months. Among the 145 responding patients, the median duration of response was 11.1 months.
The results from KEYNOTE-087 showed that most patients with relapsed or refractory classical Hodgkin lymphoma responded to treatment with KEYTRUDA, and 22 percent experienced complete remission. For the patients with classical Hodgkin lymphoma this approval is an important step forward and represents a new treatment option.
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