New Indications Approved for Keytruda
June 15, 2018 – The U.S. FDA has approved two new indications for Keytruda® (pembrolizumab), manufactured by Merck. Both new indications were granted under the FDA’s accelerated approval program. Merck may be required to provide additional data from ongoing studies to support the approval.
On June 15, 2018, the FDA granted Keytruda an indication to treat adult and pediatric patients who have relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL). In patients with relapsed PMBCL, they must have tried two or more prior lines of therapy before treatment with Keytruda. Patients who received Keytruda in clinical trials had a 45% objective response rate, and in some cases, experienced complete remission of their cancer.
On June 12, 2018, Keytruda received FDA approval to treat individuals who have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. Approval was granted based on a clinical study in which patients whose tumors expressed PD-L1 had an objective response rate of 14.3% on Keytruda. Of patients who responded to treatment with Keytruda, 91% experienced a duration of response that lasted six months or more.
This is the first approval for Keytruda to treat a gynecological cancer, and makes Keytruda the first anti-PD-1 therapy to be approved to treat advanced cervical cancer. Recommended dosing under this indication is 200mg delivered once every three weeks via intravenous (IV) infusion.
Keytruda carries numerous indications in oncology, including for treatment of melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, Hodgkin lymphoma, gastric cancer, microsatellite instability-high (MSI-H) cancer, and urothelial carcinoma. The drug originally received FDA approval in 2014.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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