Last week was quite busy for Merck (MSD outside the US and Canada) with its immunotherapy Keytruda® (pembrolizumab) obtaining not only one, but two FDA approvals.
The first of the two approvals was granted by the FDA on June 12, and approved Keytruda® for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1, as determined by an FDA-approved test.
The second approval came only one day after and approved Keytruda® for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
As such, these two new approvals bring the immunotherapy two “firsts”. First of all, Keytruda® is now the first anti-PD-1 therapy cleared for patients with advanced cervical cancer and progression on or after chemotherapy. This approval furthermore marks the first indication for the medicine in a gynecologic setting.
Secondly, Keytruda® is now also the first anti-PD-1 therapy approved for PMBCL, which is a rare type of non-Hodgkin lymphoma. The approval marks the second for the immunotherapy in the hematologic malignancy setting.
Keytruda® and cervical cancer
This indication was approved under FDA’s accelerated approval pathway. The approval was based on a clinical trial called KEYNOTE-158 and involved 98 patients. The overall results showed an objective response rate of 14.3 percent for the 77 patients whose tumors expressed PD-L1, a complete response rate of 2.6 percent and partial response rate of 11.7 percent.
Keytruda® and PMBCL
This indication was also approved under FDA’s accelerated approval pathway. This approval was based on a clinical trial called KEYNOTE-170 and involved 53 patients with relapsed or refractory PMBCL. The data from the trial showed an objective response rate of 45 percent with a complete response rate of 11 percent and a partial response rate of 34 percent.
Keytruda® (pembrolizumab) now has over 10 FDA approvals and they span over a wide variety of cancer settings such as melanoma, gastric cancer, classical Hodgkin lymphoma, urothelial carcinoma, head and neck cancer.
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Keytruda® (pembrolizumab) is a registered trademark of Merck & Co.