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

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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
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:

‡ 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.