The U.S. Food and Drug Administration (FDA) has granted accelerated approval of an additional recommended dose of Keytruda (pembrolizumab), a cancer drug, in adults, said its manufacturer Merck & Co.
The drug regulatory body approved the use of Keytruda 400 mg every 6 weeks alone or in conjunction with other drugs.
The FDA approved the additional recommended dosage of Keytruda given the complexity of the ongoing coronavirus pandemic, said Dr. Roy Baynes, Merck’s CMO.
“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” he added.
“Today’s approval of an every 6-week dosing schedule for (pembrolizumab) gives doctors an option to reduce how often patients are at the clinic for their treatment,” continued Dr. Baynes, who is the head of global clinical development at Merck.
The FDA’s approval is contingent upon clinical verification and description in the confirmatory human trials.
Previously, Keytruda was approved to be administered at the dosage of 200 mg every 3 weeks.
The FDA said some of the immune-related adverse effects of Keytruda include inflammation of the colon, lungs, liver, and kidney. Other side effects include kidney dysfunction, skin reactions, and solid organ transplant rejection.
Belonging to antineoplastic agents, Keytruda is a humanized antibody used in cancer immunotherapy, which is administered intravenously. It is indicated for the treatment of melanoma (skin cancer), lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.