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

Project Number pCODR 10206
Brand Name Rozlytrek
Generic Name Entrectinib
Strength 100 mg and 200 mg
Tumour Type Lung
Indication 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
Review Status Under Review
Pre Noc Submission Yes
NOC Date May 5, 2020
Manufacturer Hoffmann-La Roche Ltd.
Sponsor Hoffmann-La Roche Ltd.
Submission Date January 8, 2020
Submission Deemed Complete January 22, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ January 22, 2020
Check-point meeting March 25, 2020
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement 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.