Regulatory Decision Summary for Yescarta
Review decision
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.
Product type:
Contact:
Medicinal Ingredient(s):
Axicabtagene ciloleucel
Control Number:
259651
Brand/Product Name:
Yescarta
Therapeutic Area:
Antineoplastic agents
Type of Submission:
Supplement to a New Drug Submission
Decision issued:
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 obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Yescarta filed by Gilead Sciences Canada Inc.
After evaluation of the submitted data package, Health Canada authorized the following indication:
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for:
-
the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) whose disease is refractory to, or has relapsed within 12 months of, first line chemoimmunotherapy.
Why was the decision issued?
Authorization was based on one international, multi-centre, randomized, open-label, study (ZUMA-7). Patients (n = 359) with large B-cell lymphoma refractory to, or relapsed within 12 months of, first-line chemoimmunotherapy were randomized to either Yescarta (n = 180) or Standard of Care Treatment (SOCT) (n = 179), which consisted of salvage chemoimmunotherapy followed by high-dose therapy and autologous stem cell transplant (ASCT). Only patients who responded to salvage chemoimmunotherapy were eligible to receive high-dose therapy and, subsequently, ASCT.
The primary efficacy endpoint was Event Free Survival (EFS), which was significantly improved in the Yescarta treatment arm compared to the SOCT arm. The key secondary endpoint, Objective Response Rate (ORR) also showed significant improvement in favour of Yescarta.
The most important/common adverse drug reactions associated with Yescarta are cytokine release syndrome, neurological toxicities, cytopenias, hypogammaglobulinemia and infections. These reactions were well managed using current protocols. This findings were compared to the known safety profile of the SOCT, which is also remarkable for cytopenias (e.g., febrile neutropenia, thrombocytopenia), infections, gastrointestinal effects, and a risk of secondary malignancy.
Considering the improvement in efficacy over the standard of care, and the remarkable, but manageable safety profile, the benefit-risk assessment is favourable for Yescarta for the indication when used as labelled.
The target dose is 2 x 106 CAR-positive viable T cells per kg body weight (range: 1 x 106 – 2.4 x 106 cells/kg), with a maximum of 2 x 108 CAR-positive viable T cells for patients 100 kg and above
An updated Risk Management Plan (RMP) for Yescarta was reviewed by Health Canada and considered acceptable.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
For further details about Yescarta, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-12-06
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription status:
Schedule D drug
Date Filed:
2021-12-15
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| YESCARTA | 02485648 | GILEAD SCIENCES CANADA INC | AXICABTAGENE CILOLEUCEL 200000000 CELLS / BAG |