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18-06-2018 | FDA | News

approvalsWatch

Double pembrolizumab approval for advanced cervical cancer, PMBCL

medwireNews: The US FDA has expanded pembrolizumab’s indications to include the treatment of patients with recurrent or metastatic cervical cancer, and for those with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL).

Pembrolizumab is now approved for use in cervical cancer patients whose disease has progressed on or after chemotherapy and whose tumors have a combined positive score (CPS) of 1 or above on an FDA-approved companion test.

The decision follows results from the KEYNOTE-158 trial where 77 patients with recurrent or metastatic disease and a CPS score of at least 1 had an objective response rate of 14.3%.

The recommended dose is 200 mg every 3 weeks; major adverse events associated with treatment include anemia, fistula, hemorrhage and infection.

The PD-1 inhibitor also received accelerated approval for the same dosing schedule for the treatment of adult PMBCL patients with refractory disease or who have relapsed after receiving at least two lines of chemotherapy, although pembrolizumab is not recommended for those requiring urgent cytoreductive therapy. Pediatric PMBCL patients may be treated at a dose of 2 mg/kg every 3 weeks up to a maximum of 200 mg.

The KEYNOTE-170 study achieved an overall response rate of 45% among the 53 patients recruited, with a median duration of response unreached after a median 9.7 months of follow-up.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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