![]() ![]() Progress Reports of Confirmatory Trials and Other Ongoing Trials The sponsor should acknowledge that the indication authorized under the NOC/c pathway for KEYTRUDA under control #228721 can be withdrawn or revised if study Keynote-775 does not demonstrate an improvement in efficacy, compared to chemotherapy, that is both statistically and clinically significant.The sponsor should provide the approximate date of completion of the confirmatory study and should commit to an approximate date of filing of the SNDS-c.The study is expected to enroll at least 780 patients (660 of whom will be not MSI-H or dMMR) with advanced, recurrent or metastatic endometrial carcinoma who have had disease progression after one prior platinum-based chemotherapeutic regimen. This study is designed to evaluate the effect of pembrolizumab + lenvatinib on progression free survival (PFS) and overall survival (OS) when compared to chemotherapy (investigator’s choice of doxorubicin or paclitaxel). Submit, as an SNDS-c, the final report for the confirmatory study titled: A multi-center, open-label, randomized, phase 3 trial to compare the efficacy and safety of lenvatinib in combination with pembrolizumab versus treatment of physician’s choice in participants with advanced endometrial cancer (Keynote-775).A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority, of Merck Canada Inc., having a form and content satisfactory to Health Canada, as indicated in the Guidance Document: Notice of Compliance with Conditions (NOC/c), including commitments to provide the following:.consents to the posting of the NOC/c-QN on Health Canada's website. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Merck Canada Inc. ![]() A letter, signed by the Chief Executive Officer, or designated signing authority of Merck Canada Inc., indicating that you agree to have this submission considered under the NOC/c Policy.In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment: This Notice of Compliance with Conditions (NOC/c)-Qualifying Notice, issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the Supplement to a New Drug Submission (SNDS) for Keytruda (pembrolizumab), Control Number 228721, indicated for the treatment of adults patients, in combination with lenvatinib, 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, qualifies to be considered for authorisation under the NOC/c policy. Biologics and Genetic Therapies Directorate ![]()
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