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|Project Number||pCODR 10156|
|Indication||Small Cell Lung Cancer (SCLC)|
|Funding Request||For the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with a platinum-based chemotherapy and etoposide. Maintenance TECENTRIQ should be continued until loss of clinical benefit or unacceptable toxicity|
|Review Status||Notification to Implement Issued|
|Clarification||A procedural review request has been received and granted.|
|Pre Noc Submission||Yes|
|NOC Date||August 8, 2019|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||March 4, 2019|
|Submission Deemed Complete||March 18, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||March 18, 2019|
|Check-point meeting||May 7, 2019|
|pERC Meeting||September 19, 2019|
|Initial Recommendation Issued||October 3, 2019|
|Feedback Deadline ‡||October 18, 2019|
|pERC Reconsideration Meeting||November 21, 2019|
|Final Recommendation Issued||January 30, 2020|
|Notification to Implement Issued||February 14, 2020|
‡ 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.