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Halaven for Metastatic Breast Cancer - Details

Project Number pCODR 10005
Brand Name Halaven
Generic Name Eribulin Mesylate
Strength 1mg per 2 mL vial
Tumour Type Breast
Indication Metastatic Breast Cancer
Funding Request *Revised at Submitter's request For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date December 14, 2011
Manufacturer Eisai Ltd.
Submitter Eisai Ltd.
Submission Date February 9, 2012
Submission Deemed Complete February 16, 2012
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ February 24, 2012
Check-point meeting March 28, 2012
pERC Meeting May 17, 2012
Initial Recommendation Issued June 1, 2012
Feedback Deadline ‡ June 15, 2012
pERC Reconsideration Meeting July 19, 2012
Final Recommendation Issued August 2, 2012
Notification to Implement Issued August 20, 2012

‡ 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.