(Correction) FDA Approves Treatment for Hodgkin Lymphoma

The FDA has posted a correction for this press release: "The notice posted to the Hematology/Oncology Approvals web page yesterday afternoon regarding an approval for the treatment of Hodgkin lymphoma was posted in error due to a technical problem. This product approval took place in March and was previously posted on the web page and issued to this list. We apologize for any confusion or inconvenience."

The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL) or patients who have relapsed after 3 or more prior therapies.

Pembrolizumab is recommended to be administered intravenously to adult patients at a dose of 200 mg every 3 weeks, and is recommended to be administered intravenously to pediatric patients at a dose of 2 mg/kg every 3 weeks.
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The efficacy and safety of pembrolizumab was based on data from a multicenter, non-randomized, open-label clinical trial that included 210 adult patients with either refractory or relapsed cHL who had received a median of 4 prior systemic therapies. The overall response rate of patients was 69% over a median follow-up of 9.4 months, and the estimated median duration was 11.1 months.

Common adverse events associated with pembrolizumab included fatigue, pyrexia, cough, musculoskeletal pain, diarrhea, rash, and hypertransaminasemia. Other common adverse reactions included dyspnea, arthralgia, vomiting, nausea, pruritus, hypothyroidism, upper respiratory tract infections, headache, peripheral neuropathy, hyperbilirubinemia, increased creatinine, infusion reactions, pneumonitis, uveitis, myositis, myelitis, and myocarditis.

For pediatric patients, the efficacy of pembrolizumab was extrapolated from the results of adult patients. The safety of pembrolizumab was evaluated using data of 40 children with advanced melanoma, PD-L1 positive solid tumors, or lymphoma, and was found to be similar to adults. Common adverse reactions in children included fatigue, vomiting, abdominal pain, hypertransaminasemia, and hyponatremia.

In addition,  a new “warning and precaution” has been added to the drug after it was found to be associated with complications of allogeneic hematopoietic stem cell transplantation, including death. Health care professional should monitor patients closely for transplant-related complications, including hyperacute graft-versus-host-disease, severe acute hyperacute graft-versus-host-disease, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions.

—Melissa Weiss

Reference:

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy [press release]. FDA. May 14, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558604.htm. Accessed May 16, 2017.