Trastuzumab Emtansine (Kadcyla) for Early Breast Cancer (EBC) — Details


( Last Updated : February 6, 2020)
Generic Name:
Trastuzumab Emtansine
Project Status:
Complete
Therapeutic Area:
Early Breast Cancer (EBC)
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Kadcyla
Project Line:
Reimbursement Review
Project Number:
PC0182-000
NOC Date:

Details


Strength:
100 mg and 160 mg vial
Tumour Type:
Breast
Indications:
Early Breast Cancer (EBC)
Funding Request:
For the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual disease, after pre-operative systemic treatment. KADCYLA should be continued for 14 cycles or until disease progression or unacceptable toxicity. If KADCYLA is discontinued in the event of toxicity, treatment with trastuzumab may be continued to complete one year of HER2-directed therapy.
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.