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Tecentriq for Small Cell Lung Cancer – Details

Project Number pCODR 10156
Brand Name Tecentriq
Generic Name Atezolizumab
Strength 60 mg/mL
Tumour Type Lung
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 Under Review
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
Prioritization Requested
Stakeholder Input Deadline ‡ March 18, 2019
Check-point meeting May 7, 2019
pERC Meeting (target date) September 19, 2019
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.