Review decisions
Showing 10 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1774884635609
… [IHC] score of 3+ [IHC 3+]) biliary tract cancer. 1 What was approved? Ziihera, an antineoplastic … [IHC] score of 3+ [IHC 3+]) biliary tract cancer. The market authorization with conditions is based on … [IHC] score of 3+ [IHC 3+]) biliary tract cancer. Ziihera was authorized under the Guidance Document: …
Product Type: Drug
Control Number: 296499
DIN(s): 02564610
Manufacturer: Jazz Pharmaceuticals Ireland Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-03-26
Issued / Original Publication Date: 2026-04-06
Decision / Authorization Date: 2026-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1761315404285
… epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic … epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic … epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic …
Product Type: Drug
Control Number: 294637
DIN(s): 02560771
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-01-28
Issued / Original Publication Date: 2025-10-23
Decision / Authorization Date: 2025-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766066698275
… Seladelpar is a substrate of the efflux transporters breast cancer resistance protein (BCRP) and multidrug resistance … Seladelpar is a substrate of the efflux transporters breast cancer resistance protein (BCRP) and multidrug resistance …
Product Type: Drug
Control Number: 294551
DIN(s): 02561492
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-01-27
Issued / Original Publication Date: 2025-12-17
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770913249373
… lymphoma, esophageal squamous cell carcinoma, gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, small cell lung cancer, and urothelial carcinoma) who had received the same …
Product Type: Drug
Control Number: 293878
DIN(s): 02564009
Manufacturer: BeOne Medicines I GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-12-30
Issued / Original Publication Date: 2026-02-11
Decision / Authorization Date: 2025-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1759755218605
… follow-up to confirm the clinical benefit. Melanoma, a cancer that originates from melanocytes, is the most lethal form of skin cancer due to its propensity to metastasize to various organs. According to the Canadian Cancer Society, it was estimated that 11,300 new cases of …
Product Type: Drug
Control Number: 293019
DIN(s): 02560232
Manufacturer: Iovance Biotherapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-12-03
Issued / Original Publication Date: 2025-10-03
Decision / Authorization Date: 2025-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1765291966794
… of the nasopharynx. The development of nasopharyngeal cancer is thought to involve Epstein-Barr virus infection, … in vivo with syngeneic and xenograft mouse models of cancer in which toripalimab slowed the tumour growth. …
Product Type: Drug
Control Number: 290985
DIN(s): 02562219
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-01
Issued / Original Publication Date: 2025-12-08
Decision / Authorization Date: 2025-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748527113506
… accordingly. Omaveloxolone is a weak inducer of breast cancer resistance protein (BCRP) and organic anion …
Product Type: Drug
Control Number: 289541
DIN(s): 02556219
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-05-29
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760450740287
… in women with conditions such as hormone-sensitive cancers, thromboembolic disease, or active liver disease. … with proton pump inhibitors or substrates of breast cancer resistance protein (BCRP), organic anion transporting … management. No clinical safety data are available in breast cancer patients, a population with high unmet need for …
Product Type: Drug
Control Number: 289506
DIN(s): 02559714
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-10-12
Decision / Authorization Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1762969841968
… hypercalcemia, and/or weight loss. In 2024, the Canadian Cancer Society projected that 4,100 Canadians would be … with hepatic impairment. Hepatic function, as per National Cancer Institute Organ Dysfunction Working Group …
Product Type: Drug
Control Number: 288908
DIN(s): 02559617, 02559625
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-07-25
Issued / Original Publication Date: 2025-11-10
Decision / Authorization Date: 2025-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1753452540480
… project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The submission for Vanflyta was … and is a substrate of p-glycoprotein (P-gp), but not breast cancer resistance protein (BCRP), while its active …
Product Type: Drug
Control Number: 288150
DIN(s): 02558351, 02558378
Manufacturer: Daiichi Sankyo Pharma Canada Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-28
Issued / Original Publication Date: 2025-07-24
Decision / Authorization Date: 2025-06-09