rimegepant

Details

Key Milestones2
Call for patient/clinician input open04-Jul-23
Call for patient/clinician input closed25-Aug-23
Submission received15-Aug-23
Submission accepted29-Aug-23
Review initiated30-Aug-23
Clarification:

- Submission temporarily suspended

-Voluntarily withdrawn by the sponsor on 26 Sep 2023

talazoparib

Details

Key Milestones2
Call for patient/clinician input openJuly 04, 2023
Call for patient/clinician input closedAugust 25, 2023
Clarification:

- Patient input submission received from Canadian Cancer Society

Submission receivedAugust 15, 2023
Submission acceptedAugust 29, 2023
Review initiatedAugust 30, 2023
Draft CADTH review report(s) provided to sponsor for commentNovember 16, 2023
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Deadline for sponsors commentsDecember 06, 2023
Clarification:

- Voluntarily withdrawn by the sponsor on 19 February 2025

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

Multiple Myeloma

Details

Review Type: Rapid

Provisional Funding Algorithm

Draft Report Posted: June 22, 2023
Stakeholder Feedback Deadline: June 29, 2023
Final Report Posted : July 27, 2023

 

 

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

Details

See Pharmaceutical Reviews Update ― Issue 38 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

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