Xalkori for ROS1-positive advanced Non-Small Cell Lung 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.

Ibrance (with Faslodex) for Advanced or Metastatic Breast 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.

Unituxin for Neuroblastoma – 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.

telotristat

Details

Key Milestones2

Call for patient input posted August 29, 2018
Patient group input closed October 19, 2018
Clarification:

- Patient input submission received from the Carcinoid Neuroendocrine Tumour Society - Canada

Patient input summary sent for review to patient input groups October 29, 2018
Patient group comments on input summary closed November 05, 2018
Clarification:

- Patient input summary feedback received

Submission received September 27, 2018
Submission accepted for review October 12, 2018
Review initiated October 15, 2018
Draft Canada's Drug Agency review report(s) sent to sponsor January 07, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received January 16, 2019
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received January 23, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor February 07, 2019
Canadian Drug Expert Committee (CDEC) meeting February 20, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans March 06, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received March 22, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

- Target CDEC reconsideration meeting date to be determined

Sponsor's request for reconsideration placed on CDEC agenda June 19, 2019
CDEC Final Recommendation issued to sponsor and drug plans June 26, 2019
CDEC Final Recommendation posted July 03, 2019
Final Canada's Drug Agency review report(s) posted July 25, 2019

Xtandi for non-metastatic Castration-Resistant Prostate 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.

Imfinzi for Non-Small Cell Lung 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.

Tafinlar & Mekinist in combo Melanoma Adjuvant Therapy – 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.

Vizimpro for Non-Small Cell Lung 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.

Cabometyx for Renal Cell Carcinoma 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.

Keytruda for Non-Squamous NSCLC – 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.