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|Project Number||pCODR 10153|
|Strength||25 mg/mL & 50 mg/vial|
|Funding Request||In combination with pemetrexed and platinum chemotherapy, for the treatment of metastatic non-squamous NSCLC, in adults with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||March 13, 2019|
|Submission Date||September 14, 2018|
|Submission Deemed Complete||September 28, 2018|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||September 28, 2018|
|Check-point meeting||December 11, 2018|
|pERC Meeting||March 21, 2019|
|Initial Recommendation Issued||April 4, 2019|
|Feedback Deadline ‡||April 18, 2019|
|pERC Reconsideration Meeting||May 16, 2019|
|Final Recommendation Issued||May 31, 2019|
|Notification to Implement Issued||June 17, 2019|
‡ 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.