The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) who are refractory or have relapsed after 3 or more lines of therapy.
For safety data, the FDA asessed a study of 40 pediatric patients with advanced melanoma, PD-L1–positive advanced, relapsed, or refractory solid tumors, or lymphoma. The safety profile in the pediatric patients was consistent to that observed in adults. Some adverse events occurred at a higher rate (≥15% difference) in children than in adults, including fatigue, vomiting, abdominal pain, hypertransaminasemia, and hyponatremia. Pembrolizumab exposure at a dose of 2 mg/kg every 3 weeks in these pediatric patients was comparable to that observed in adults.
Pembrolizumab’s label has also been updated with a new "Warning and Precaution" for complications of allogeneic hematopoietic stem cell transplantation after treatment with the PD-1 inhibitor. The warning informs healthcare professionals to monitor patients closely for early signals of transplant-related complications, such as hyperacute GVHD, grade 3/4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions.
The acclerated approval of pembrolizumab in cHL is contingent upon the results of a confirmatory trial verifying the benefit of the PD-1 inhibitor in this setting.
Pembrolizumab has approvals in melanoma, lung cancer, and head and neck cancer. Other applications for approval are pending with the FDA in bladder cancer and microsatellite instability-high cancer, as a monotherapy, and in combination with chemotherapy for patients with lung cancer.
“The results from KEYNOTE-087 showed that most patients with relapsed or refractory classical Hodgkin lymphoma responded to treatment with Keytruda, and 22% experienced complete remission,” Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, said in a statement. “Today’s approval—the first for Keytruda in a hematologic malignancy—reinforces the hope that immunotherapy will prove useful in a wide variety of cancers.”
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