drospirenone

Details

Key Milestones2
Call for patient/clinician input open30-Jun-23
Call for patient/clinician input closed25-Aug-23
Clarification:

- No patient input submission received

Submission received14-Aug-23
Submission accepted30-Aug-23
Review initiated31-Aug-23
Clarification:

- Submission was not accepted for review on 28 Aug 2023

Draft Canada's Drug Agency review report(s) provided to sponsor for comment24-Nov-23
Deadline for sponsors comments05-Dec-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor12-Jan-24
Expert committee meeting (initial)24-Jan-24
Draft recommendation issued to sponsor06-Feb-24
Draft recommendation posted for stakeholder feedback15-Feb-24
End of feedback period01-Mar-24
Final recommendation issued to sponsor and drug plans18-Mar-24
Final recommendation posted04-Apr-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)02-Apr-24
Canada's Drug Agency review report(s) posted25-Jul-24

CADTH Pharmaceutical Reviews Update — Issue 39

Details

See Pharmaceutical Reviews Update ― Issue 39 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

  • updated procedures for streamlined drug class reviews.

Canada's Drug Agency Program Updates

1. Updated Procedures for Streamlined Drug Class Reviews

belumosudil

Details

Key Milestones2
Call for patient/clinician input open14-Jun-23
Call for patient/clinician input closed04-Aug-23
Clarification:

- Patient input submission received from the Leukemia & Lymphoma Society of Canada

Submission received26-Jul-23
Submission accepted10-Aug-23
Review initiated11-Aug-23
Draft CADTH review report(s) provided to sponsor for comment02-Nov-23
Deadline for sponsors comments14-Nov-23
CADTH review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor10-Jan-24
Draft recommendation posted for stakeholder feedback18-Jan-24
End of feedback period02-Feb-24
Final recommendation posted05-Mar-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Mar-24
CADTH review report(s) posted01-May-24

metreleptin

Details

Key Milestones2
Call for patient/clinician input open13-Jun-23
Call for patient/clinician input closed04-Aug-23
Clarification:

- Patient input submission received from the Lipodystrophy Canada Foundation

Submission received25-Jul-23
Submission accepted09-Aug-23
Review initiated10-Aug-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment26-Oct-23
Deadline for sponsors comments06-Nov-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor22-Jan-24
Draft recommendation posted for stakeholder feedback01-Feb-24
End of feedback period15-Feb-24
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting24-Apr-24
Final recommendation issued to sponsor and drug plans09-May-24
Final recommendation posted28-May-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)24-May-24
Clarification:

- Extension requested by sponsor

Canada's Drug Agency review report(s) posted10-Oct-24

CADTH Pharmaceutical Reviews Update — Issue 38

glofitamab

Details

Key Milestones2
Call for patient/clinician input openJune 06, 2023
Call for patient/clinician input closedJuly 28, 2023
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedJuly 18, 2023
Submission acceptedAugust 01, 2023
Review initiatedAugust 02, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentOctober 19, 2023
Deadline for sponsors commentsOctober 30, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 20, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 02, 2024
Final recommendation postedFebruary 21, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)February 16, 2024
Canada's Drug Agency review report(s) postedApril 22, 2024

sacituzumab govitecan

Details

Key Milestones2
Call for patient/clinician input openJune 06, 2023
Call for patient/clinician input closedJuly 28, 2023
Clarification:

- Patient input submission received from Breast Cancer Canada and McPeak-Sirois Group for Clinical Research in Breast Cancer Research, Canadian Breast Cancer Network and Rethink Breast Cancer

Submission receivedJuly 18, 2023
Submission acceptedAugust 01, 2023
Review initiatedAugust 02, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 19, 2023
Deadline for sponsors commentsOctober 30, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 19, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 01, 2024
Final recommendation postedFebruary 20, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 15, 2024
CADTH review report(s) postedApril 25, 2024

treosulfan

Details

Key Milestones2
Call for patient/clinician input openJune 02, 2023
Call for patient/clinician input closedJuly 28, 2023
Clarification:

- Patient input submission received from The Leukemia & Lymphoma Society of Canada (LLSC)

Submission receivedJuly 14, 2023
Submission acceptedAugust 08, 2023
Clarification:

- Submission was not accepted for review on 28 Jul 23

Review initiatedAugust 09, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentNovember 09, 2023
Deadline for sponsors commentsNovember 21, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorDecember 21, 2023
Expert committee meeting (initial)January 10, 2024
Draft recommendation issued to sponsorJanuary 22, 2024
Draft recommendation posted for stakeholder feedbackFebruary 01, 2024
End of feedback periodFebruary 15, 2024
Final recommendation issued to sponsor and drug plansFebruary 28, 2024
Final recommendation postedMarch 18, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)March 13, 2024
Canada's Drug Agency review report(s) postedJune 06, 2024

nivolumab and relatlimab

Details

Key Milestones2
Call for patient/clinician input open30-May-23
Call for patient/clinician input closed21-Jul-23
Clarification:

- Patient input submission received from Melanoma Canada and Save Your Skin Foundation

Submission received10-Jul-23
Submission accepted24-Jul-23
Review initiated25-Jul-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment19-Oct-23
Deadline for sponsors comments30-Oct-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor24-Nov-23
Expert committee meeting (initial)06-Dec-23
Draft recommendation issued to sponsor18-Dec-23
Draft recommendation posted for stakeholder feedback04-Jan-24
End of feedback period18-Jan-24
Final recommendation issued to sponsor and drug plans02-Feb-24
Final recommendation posted21-Feb-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)16-Feb-24
Canada's Drug Agency review report(s) posted01-May-24