Pembrolizumab was approved for children and adults with cHL that is resistant to therapy and for those who have relapsed after at least three prior lines of therapy.
Pembrolizumab was previously approved for head and neck cancer, malignant melanoma and non-small cell lung cancer.
The FDA based pembrolizumab’s latest approval on data from 210 adult patients with cHL. These patients appeared to have high overall response rates. Response to pembrolizumab in children was assumed to be similar to that seen in adults
The medication was also assessed in 40 children with advanced melanoma, certain tumors or lymphoma. Some adverse reactions occurred at higher rates in children than in adults.
The FDA also added a new “Warning and Precaution” noting potentially deadly complications observed with stem cell transplantation after taking pembrolizumab.
The most commonly reported adverse reactions included liver injury, rash, diarrhea, musculoskeletal pain, cough, fever and fatigue. Also, some patients had kidney dysfunction, headache, upper respiratory tract infections, itchy skin, nausea, vomiting and other reactions.
Pembrolizumab is given by a health care professional as an injection, according to the FDA.