Review decisions
Showing 190 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00283
… large cell lymphoma (BIA-ALCL), a rare but serious type of cancer that affects the immune system Key Messages Health … large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system linked with breast implants. … is a serious but rare type of non-Hodgkin lymphoma, a cancer that affects the immune system, that may develop many …
Issued / Original Publication Date: 2022-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00627
… on organic anion transporting polypeptide (OATP), breast cancer resistance protein (BCRP), and P-gp transporters; as …
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-06
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734963810994
… a comparative immunogenicity study in patients with breast cancer. Based on Health Canada’s review , the benefit-risk … use has not been authorized. Of the 930 subjects with cancer who received pegfilgrastim in clinical studies, … immunogenicity study conducted in patients with breast cancer receiving myelosuppressive chemotherapy (Study …
Product Type: Drug
Control Number: 262990
DIN(s): 02550857
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Issued / Original Publication Date: 2024-12-22
Decision / Authorization Date: 2024-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00941
… with locally advanced or metastatic non-small cell lung cancer with activating epidermal-growth factor receptor exon … with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor … with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor …
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2022-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1704300260963
… drug. As of 2022, approximately 3,500 new cases of liver cancer are diagnosed each year in Canada and 1,650 Canadians … from hepatocytes, which accounts for 75 to 85% of all liver cancers. Some of the most common risk factors for HCC … treatment. Patients with a Barcelona Clinic Liver Cancer (BCLC) Stage D who are unfit for systemic therapy are …
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Issued / Original Publication Date: 2024-01-03
Decision / Authorization Date: 2023-08-31
Updated Date: 2024-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00936
… treatment of women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. … for: the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based … chemotherapy and who have recurrent or metastatic cervical cancer. A total of 608 patients were randomized 1:1 to …
Product Type: Drug
Control Number: 256178
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-30
Decision / Authorization Date: 2022-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975
… are available for this population. Of the 930 patients with cancer who received pegfilgrastim in clinical studies, 139 … chemotherapy therapy after surgical resection of breast cancer, in accordance with the Guidance Document: … active-controlled, parallel-group study in breast cancer patients undergoing adjuvant myelosuppressive …
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-23
Issued / Original Publication Date: 2024-11-07
Decision / Authorization Date: 2024-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684955300002
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). … 10% of hematological malignancies. The Canadian Cancer Society estimated that in 2022 approximately …
Product Type: Drug
Control Number: 262122
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-03-04
Issued / Original Publication Date: 2023-05-09
Decision / Authorization Date: 2023-02-09
Updated Date: 2025-05-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00926
… or metastatic melanoma, metastatic Non-Small Cell Lung Cancer (NSCLC), microsatellite Instability-High (MSI-H)/ … mismatch Repair Deficient (dMMR) metastatic Colorectal Cancer, and unresectable Malignant Pleural Mesothelioma …
Product Type: Drug
Control Number: 255450
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-04
Decision / Authorization Date: 2022-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00931
… choice in participants with advanced endometrial cancer. In addition, summary of results in endometrial cancer patients from the following supportive studies were … 2 study of lenvatinib in subjects with advanced endometrial cancer and disease progression following first-line …
Product Type: Drug
Control Number: 252195
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-05-03
Decision / Authorization Date: 2022-02-24