On June 12-13, FDA approved two new indications for K drug, just the day before the K drug was approved for the treatment of cervical cancer. One day later, the US FDA approved pembrolizumab (Keytruda, pembrolizumab) for the treatment of adults and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) who had relapsed after at least two lines of treatment .
The approval was based on data from 53 patients with relapsed or refractory PMBCL from the multicenter, open label, single arm trial KEYNOTE-170 (NCT02576990). Patients received 200 mg of Pembrolizumab intravenously every 3 weeks until unacceptable toxicity or disease progression, or up to 24 months for patients who did not progress. The overall effective rate is 45%, including 11% complete remission and 34% partial remission. During the follow-up period (median was 9.7 months), the median response time was not reached. The median time for the first objective response was 2.8 months. Pembrolizumab is not recommended for patients with PMBCL who require emergency tumor reduction.
In KEYNOTE-170, the most common adverse reactions in patients with ≥10% PMBCL are musculoskeletal pain, upper respiratory tract infection, fever, fatigue, cough, dyspnea, diarrhea, abdominal pain, nausea, arrhythmia and headache. Pembrolizumab was discontinued or discontinued due to adverse reactions in 8% and 15% of patients, respectively. 25% of patients had adverse reactions requiring systemic corticosteroid treatment, and 26% of patients had serious adverse reactions.