Regulatory Decision Summary for Trodelvy
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Type of Submission:
Supplement to a New Drug Submission - Priority Review
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to gain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Trodelvy, submitted by Gilead Sciences Canada Inc.
This Supplement to a New Drug Submission was filed to obtain market authorization for:
“Trodelvy (sacituzumab govitecan) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.”
Previously, Trodelvy was authorized for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
The Supplement to a New Drug Submission for Trodelvy was filed under the Priority Review Policy.
The submission was reviewed under the international review work sharing model, Project Orbis (Type B).
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
Authorization was based on the safety and efficacy results from a Phase III, international, multi-centre, randomized, open-label, controlled clinical trial, IMMU-132-109 (TROPiCS-02). Patients (n = 543) with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer received either Trodelvy (10 mg/kg intravenously on Day 1 and 8 of a 21-day cycle) (n = 272) or treatment of physician’s choice (TPC) (either eribulin, vinorelbine, gemcitabine or capecitabine [either intravenously or orally]) (n = 271). Dose selection was based on the results from a Phase I/II basket trial, IMMU-132-01.
The primary efficacy endpoints were progression-free survival (PFS) and overall survival (OS) in the all-randomized population. At the first interim analysis, the Trodelvy arm demonstrated statistically and clinically significant PFS results in the all-randomized population. OS was not mature at this interim analysis. At the following interim analysis, OS was statistically and clinically significant as patients in the Trodelvy arm had a median survival of 14.4 months compared to those in the TPC arm with 11.2 months.
The most common adverse reactions reported in at least 1% of patients were: neutropenia, diarrhea, nausea, alopecia, fatigue, anemia, and constipation. These safety findings were consistent with previous observations. In this Phase III trial, elderly patients had higher rates of serious adverse reactions, dose reductions and discontinuation compared to younger patients. This information has been included in the product monograph for the benefit of patients and health professionals.
The recommended dose of the drug is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of a 21-day treatment cycle.
Health Canada granted this application priority review.
An updated Risk Management Plan (RMP) for Trodelvy was reviewed by Health Canada and considered acceptable.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
The overall, the benefit-harm-uncertainty profile is favourable for Trodelvy and 180 mg/vial for the recommended indication. A Notice of Compliance (NOC) was issued.
For further details about Trodelvy, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
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Drug Identification Number(s) Issued:
Available by prescription only