Canada’s Drug Agency | Drugs, Health Technologies and Systems.

tocilizumab

Details

Key Milestones2
Call for patient input posted August 25, 2017
Patient group input closed October 17, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups October 23, 2017
Patient group comments on input summary closed October 30, 2017
Clarification:

- Patient input summary feedback received
Submission received September 25, 2017
Submission accepted for review October 10, 2017
Review initiated October 11, 2017
Draft CDR review report(s) sent to applicant December 21, 2017
Comments from applicant on draft CDR review report(s) received January 09, 2018
Redaction requests from applicant on draft CDR review report(s) received January 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant February 08, 2018
Canadian Drug Expert Committee (CDEC) meeting February 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans March 06, 2018
Embargo period ended and validation of redacted CDR review report(s) received March 20, 2018
CDEC Final Recommendation issued to applicant and drug plans March 27, 2018
CDEC Final Recommendation posted March 29, 2018
Final CDR review report(s) and patient input posted April 24, 2018
Last Updated : April 30, 2018

Lartruvo for Advanced Soft Tissue Sarcoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : May 3, 2018

Vectibix for Left Sided Metastatic Colorectal Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 16, 2018

infliximab

Details

Key Milestones2

Call for patient input postedAugust 04, 2017
Patient group input closedSeptember 26, 2017

Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 05, 2017
Patient group comments on input summary closedOctober 13, 2017

Clarification:

- Patient input summary feedback received

Submission receivedSeptember 05, 2017
Submission accepted for reviewSeptember 19, 2017
Review initiatedSeptember 20, 2017
Draft Canada's Drug Agency review report(s) sent to sponsorNovember 28, 2017
Comments from sponsor on draft Canada's Drug Agency review report(s) receivedDecember 07, 2017
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) receivedDecember 14, 2017
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsorJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plansJanuary 29, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) receivedFebruary 12, 2018
CDEC Final Recommendation issued to sponsor and drug plansFebruary 20, 2018
CDEC Final Recommendation postedFebruary 22, 2018
Final Canada's Drug Agency review report(s) and patient input postedApril 24, 2018
Last Updated : November 6, 2019

nitisinone

Details

Key Milestones2
Call for patient input posted July 28, 2017
Patient group input closed September 19, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups October 05, 2017
Patient group comments on input summary closed October 13, 2017
Clarification:

- Patient input summary feedback received
Submission received August 29, 2017
Submission accepted for review September 13, 2017
Review initiated September 14, 2017
Draft Canada's Drug Agency review report(s) sent to sponsor November 27, 2017
Comments from sponsor on draft Canada's Drug Agency review report(s) received December 06, 2017
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received December 13, 2017
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor January 05, 2018
Canadian Drug Expert Committee (CDEC) meeting January 17, 2018
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans January 30, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received February 13, 2018
CDEC Final Recommendation issued to sponsor and drug plans February 21, 2018
CDEC Final Recommendation posted February 23, 2018
Final Canada's Drug Agency review report(s) and patient input posted April 18, 2018
Last Updated : October 29, 2019

guselkumab

Details

Key Milestones2

Call for patient input postedJuly 27, 2017
Patient group input closedSeptember 18, 2017

Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsSeptember 22, 2017
Patient group comments on input summary closedSeptember 29, 2017

Clarification:

- Patient input summary feedback received

Submission receivedAugust 25, 2017
Submission accepted for reviewSeptember 11, 2017
Review initiatedSeptember 12, 2017
Draft CDR review report(s) sent to applicantNovember 24, 2017
Comments from applicant on draft CDR review report(s) receivedDecember 05, 2017
Redaction requests from applicant on draft CDR review report(s) receivedDecember 12, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedFebruary 13, 2018
CDEC Final Recommendation issued to applicant and drug plansFebruary 21, 2018
CDEC Final Recommendation postedFebruary 23, 2018
Final CDR review report(s) and patient input postedMarch 14, 2018
Last Updated : April 5, 2018

Alecensaro for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (second line) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 16, 2018

Adcetris for Hodgkin’s Lymphoma (post-ASCT) Resubmission – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : March 8, 2018

sofosbuvir velpatasvir voxilaprevir

Details

Key Milestones2
Call for patient input posted July 07, 2017
Patient group input closed August 28, 2017
Clarification:

Patient input submission received
Patient input summary sent for review to patient input groups August 30, 2017
Patient group comments on input summary closed September 07, 2017
Clarification:

- Patient input summary feedback received
Submission received July 28, 2017
Submission accepted for review August 14, 2017
Review initiated August 15, 2017
Draft CDR review report(s) sent to applicant October 30, 2017
Comments from applicant on draft CDR review report(s) received November 08, 2017
Redaction requests from applicant on draft CDR review report(s) received November 15, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant December 01, 2017
Canadian Drug Expert Committee (CDEC) meeting December 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans January 02, 2018
Embargo period ended and validation of redacted CDR review report(s) received January 16, 2018
CDEC Final Recommendation issued to applicant and drug plans January 23, 2018
CDEC Final Recommendation posted January 25, 2018
Final CDR review report(s) and patient input posted February 07, 2018
Last Updated : April 5, 2018

Keytruda for Metastatic Urothelial Carcinoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : March 19, 2018