Regulatory Decision Summary for Keytruda

 

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

February 24, 2022

What was the purpose of this submission?

The sponsor filed a Supplemental New Drug Submission (SNDS) for Keytruda (pembrolizumab), for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, when used in combination with lenvatinib.

What did the company submit to support its submission?

The Sponsor submitted efficacy and safety results from the pivotal clinical study, Study 309/KEYNOTE-775, a multicenter, open-label, randomized, phase 3 study to compare the lenvatinib in combination with pembrolizumab versus treatment of physician’s choice in participants with advanced endometrial cancer. In addition, summary of results in endometrial cancer patients from the following supportive studies were submitted:

• Study KEYNOTE-158, a single-arm, multisite, multicohort, open-label trial of pembrolizumab in previously treated participants who have locally advanced unresectable or metastatic solid tumors.
• Study 111/KEYNOTE-146, a multicenter, open-label phase 1b/2 trial of lenvatinib plus pembrolizumab in subjects with selected solid tumors.
• Study 204, an open-label, single-arm, multicenter phase 2 study of lenvatinib in subjects with advanced endometrial cancer and disease progression following first-line chemotherapy.
• Study KEYNOTE-028, a phase 1b study of pembrolizumab in subjects with select advanced solid tumors.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

After review of the data provided, Health Canada did not agree that the Sponsor had sufficiently characterized the benefit/risk profile for the proposed indication. To address Health Canada’s concern, the Sponsor sought to revise the proposed indication to that which has been conditionally approved. As new information is required to support Health Canada’s review of the modified indication, the Sponsor chose to withdraw the submission without prejudice to re-filing.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using this treatment option under SAP or in clinical trials.

Keytruda continues to be authorized with conditions for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation, when used in combination with lenvatinib.

In addition, Keytruda is authorized with conditions for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR endometrial cancer whose tumours have progressed following prior therapy and who have no satisfactory alternative treatment options, as monotherapy.

Additional information

*Proposed Brand Name:

KEYTRUDA