| Project Number | pCODR 10206 |
|---|---|
| Brand Name | TBD |
| Generic Name | Entrectinib |
| 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 | Suspended |
| Clarification | The timeline of the review has been temporarily suspended, pending the receipt of additional information from the sponsor. |
| Pre Noc Submission | Yes |
| NOC Date | |
| 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.