Review decisions
Showing 50 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747926145388
… in adult patients with melanoma and non-small-cell lung cancer. The majority of all-grade AEs reported in at least …
Product Type: Drug
Control Number: 270381
DIN(s): 02409607, 02409615, 02540053
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1743436509830
… receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. fulvestrant for … HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy or following … HR-positive HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy, was supported …
Product Type: Drug
Control Number: 262779
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-02-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742493092656
… serious health risks, notably the potential for endometrial cancer with unopposed estrogen therapy and breast cancer with combined estrogen and progestin therapy. As a …
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1745430108554
… disease progression. Patients who received prior anti-cancer treatment, including chemotherapy or radiation … randomization to the initiation of first subsequent anticancer therapy or death of any cause) compared with placebo …
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Decision / Authorization Date: 2024-08-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1755021312163
… growth factor receptor 2 (HER2) negative gastric or GEJ cancer whose tumours were Claudin 18.2 positive. In both …
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-15
Decision / Authorization Date: 2024-12-13
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/RDS1734622818009
… with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom prostate-specific membrane antigen … of care in metastatic castration-resistant prostate cancer patients (mCRPC). Only patients with PSMA-positive …
Product Type: Drug
Control Number: 279567
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-06
Decision / Authorization Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1733492722458
… Potential Safety Issue Secondary T-cell malignancy (a new cancer, that forms in a type of white blood cells called … after starting CAR-T therapy to treat other forms of blood cancers) Key Messages Health Canada’s safety review found a … for sale in Canada for the treatment of various blood cancers, including certain types of leukemia (cancer in the …
DIN(s): 02480514, 02485648, 02516667, 02527138, 02532719, 02535270
Issued / Original Publication Date: 2024-12-11
Updated Date: 2024-12-11
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/SSR1731422768944
… in Canada to treat adults with certain types of leukemia (cancer in the blood and bone marrow). Dasatinib has been …
DIN(s): 02293129, 02293137, 02293145, 02320193, 02360810, 02360829, 02470705, 02470713, 02470721, 02478307, 02478315, 02478323, 02478331, 02478358, 02481499, 02481502, 02499282, 02499304, 02499312, 02499320, 02499339, 02499347, 02514737, 02514745, 02514753, 02514761, 02514788, 02514796
Issued / Original Publication Date: 2024-11-15
Updated Date: 2024-11-15