pembrolizumab

Details

Key Milestones2
Call for patient/clinician input open04-Oct-24
Call for patient/clinician input closed02-Dec-24
Submission received14-Nov-24
Submission accepted28-Nov-24
Review initiated29-Nov-24
Draft CADTH review report(s) provided to sponsor for comment21-Feb-25
Deadline for sponsors comments04-Mar-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Mar-25
Expert committee meeting (initial)09-Apr-25
Draft recommendation issued to sponsor23-Apr-25
Draft recommendation posted for stakeholder feedback01-May-25
End of feedback period15-May-25

lazertinib and amivantamab

Details

Key Milestones2
Call for patient/clinician input open04-Oct-24
Call for patient/clinician input closed02-Dec-24
Submission received18-Dec-24
Submission accepted09-Jan-25
Review initiated10-Jan-25
Draft CADTH review report(s) provided to sponsor for comment28-Mar-25
Deadline for sponsors comments08-Apr-25
CDA-AMC review report(s) and responses to comments provided to sponsor02-May-25
Expert committee meeting (initial)14-May-25
Draft recommendation issued to sponsorMay 27, 2025
To
May 29, 2025
Draft recommendation posted for stakeholder feedback05-Jun-25
End of feedback period19-Jun-25

amivantamab

Details

Key Milestones2
Call for patient/clinician input openOctober 04, 2024
Call for patient/clinician input closedDecember 02, 2024
Submission receivedFebruary 20, 2025
Submission acceptedMarch 06, 2025
Review initiatedMarch 07, 2025
Draft CADTH review report(s) provided to sponsor for commentMay 26, 2025
Deadline for sponsors commentsJune 04, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorJune 26, 2025
Expert committee meeting (initial)July 09, 2025
Draft recommendation issued to sponsorJuly 21, 2025
To
July 23, 2025
Draft recommendation posted for stakeholder feedbackJuly 29, 2025
End of feedback periodAugust 13, 2025

Non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation

durvalumab

Details

Key Milestones2
Call for patient/clinician input open02-Oct-24
Call for patient/clinician input closed25-Nov-24
Submission received15-Nov-24
Submission accepted29-Nov-24
Review initiated02-Dec-24
Draft CADTH review report(s) provided to sponsor for comment24-Feb-25
Deadline for sponsors comments05-Mar-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Mar-25
Expert committee meeting (initial)09-Apr-25
Draft recommendation issued to sponsor24-Apr-25
Draft recommendation posted for stakeholder feedback01-May-25
End of feedback period15-May-25

Pharmaceutical Reviews Update — Issue 51

Details

Program Updates 

1. Update to Ethics Review Component of Complex Reviews

The description of the Ethics Review for Complex Reviews has been updated to further clarify the domains of ethical considerations explored within each review and the use of summary reports where appropriate. The linked Ethics Review Report template has been removed to reflect a customized approach to the reporting of ethical considerations based on the complexity of ethical issues present.

delgocitinib

Details

Key Milestones2
Call for patient/clinician input openSeptember 19, 2024
Call for patient/clinician input closedNovember 12, 2024
Submission receivedNovember 25, 2024
Submission accepted-
Clarification:

- Submission was not accepted for review on 09 Dec 2024

isatuximab

Details

Key Milestones2
Call for patient/clinician input open17-Sep-24
Call for patient/clinician input closed12-Nov-24
Submission received30-Oct-24
Submission accepted14-Nov-24
Review initiated15-Nov-24
Draft CADTH review report(s) provided to sponsor for comment24-Feb-25
Deadline for sponsors comments05-Mar-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Mar-25
Expert committee meeting (initial)09-Apr-25
Draft recommendation issued to sponsor24-Apr-25
Draft recommendation posted for stakeholder feedback01-May-25
End of feedback period15-May-25

teprotumumab

Details

Key Milestones2
Call for patient/clinician input open12-Sep-24
Call for patient/clinician input closed04-Nov-24
Submission received25-Oct-24
Submission accepted08-Nov-24
Review initiated12-Nov-24
Draft CADTH review report(s) provided to sponsor for comment07-Feb-25
Deadline for sponsors comments19-Feb-25
Clarification:

- Voluntarily withdrawn by the sponsor