Alecensaro for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (second line) – Details

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Generic Name:
Alectinib
Project Status:
Complete
Therapeutic Area:
Anaplastic Lymphoma Kinase-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Alecensaro
Project Line:
Reimbursement Review
Project Number:
PC0114-000
NOC Status at Filing:
Post NOC
Strength:
150 mg
Tumour Type:
Lung
Indications:
Locally advanced or metastatic non-small cell lung cancer (second line)
Funding Request:
As monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib until loss of clinical benefit
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Not Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation 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.