ABECMA SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IDECABTAGENE VICLEUCEL

Available from:

CELGENE INC

ATC code:

L01XL07

INN (International Name):

IDECABTAGENE VICLEUCEL

Dosage:

520000000CELLS

Pharmaceutical form:

SUSPENSION

Composition:

IDECABTAGENE VICLEUCEL 520000000CELLS

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

GENE THERAPY

Product summary:

Active ingredient group (AIG) number: 0162927001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-05-26

Summary of Product characteristics

_ABECMA (idecabtagene vicleucel) _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ABECMA
TM
Idecabtagene vicleucel
Cell suspension in one or more patient specific infusion bag(s),
target dose of 450 x 10
6
CAR-positive T cells within a range of 275 to 520 x 10
6
CAR-positive T cells, for intravenous
infusion
Professed Standard
Other antineoplastic agent (Anatomical Therapeutic Chemical index
code: L01X)
“Abecma (idecabtagene vicleucel), a B-cell maturation antigen
(BCMA)-directed genetically
modified autologous T cell immunotherapy, indicated for:

the treatment of adult patients with multiple myeloma who have
received at least three
prior therapies, including an immunomodulatory agent, a proteasome
inhibitor, and an
anti-CD38 antibody and who are refractory to their last treatment.
has been issued market authorization with conditions, pending the
results of trials to verify its
clinical benefit. Patients should be advised of the nature of the
authorization. For further
information for Abecma please refer to Health Canada’s Notice of
Compliance with
conditions - drug products web site: https://www.canada.ca/en/health-
canada/services/drugs-health-products/drugproducts/notice-compliance/conditions.html”
Celgene Inc., a Bristol Myers Squibb company
2344 Alfred-Nobel
Suite 300
Saint-Laurent, Quebec
H4S 0A4
Date of Initial Authorization:
May 26, 2021
Date of Revision:
July 30, 2021
Submission Control Number: 244266
© 2021 Celgene Corporation
Abecma is a trademark of Celgene Corporation, used under license by
Celgene Inc.
_ _
_Abecma (idecabtagene vicleucel) _
_Page 2 of 33_
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
An NOC/c is a form of market approval granted to a product on the
basis of promising
evidence of clinical effectiveness following review of the submission
by Health Canada.
Products authorized under Health Canada’s NOC/c policy are intended
for the treatment,
prevention or diagnosis of a serious, life-threatening or severely
debilitating illness. They