KEYTRUDA® approved by the FDA twice in one week

KEYTRUDA® approved by the FDA twice in one week
June 15, 2018 Sofie Svendsen
In News

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.

 

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