CDA | Evidence Driven
CDA | Evidence Driven

Entrectinib (Rozlytrek) for ROS1-positive Non-Small Cell Lung Cancer

Details

Files
Generic Name:
Entrectinib
Project Status:
Complete
Therapeutic Area:
ROS1-positive NSCLC
Manufacturer:
Hoffmann-La Roche Ltd.
Brand Name:
Rozlytrek
Project Line:
Reimbursement Review
Project Number:
PC0206-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Strength:
100 mg and 200 mg
Tumour Type:
Lung
Indications:
ROS1-positive Non-Small Cell Lung Cancer
Funding Request:
For the first-line treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Ltd.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

Entrectinib (Rozlytrek) ROS1-positive NSCLC – pERC Final Recommendation Final Recommendation January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Final Economic Guidance Report Guidance Report January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Final Clinical Guidance Report Guidance Report January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – pERC Initial Recommendation Initial Recommendation January 8, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – PAG Feedback on Initial Recommendation Feedback January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Manufacturer Feedback on Initial Recommendation Feedback January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Patient Advocacy Group Feedback on Initial Recommendation Feedback January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Clinician Feedback on Initial Recommendation Feedback January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Patient Advocacy Group COI Declarations COI Declarations January 27, 2021 View PDF
Entrectinib (Rozlytrek) ROS1-positive NSCLC – Clinician COI Declarations COI Declarations January 27, 2021 View PDF

‡ 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 : February 11, 2021