Review decisions
Showing 70 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722962428155
… and combination indications to treat many types of cancers (e.g. melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, triple negative breast cancer, head and neck squamous cell carcinoma, cervical …
Product Type: Drug
Control Number: 273487
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-20
Decision / Authorization Date: 2024-03-21
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1758215873791
… of Alyftrek with P-glycoprotein (P-gp) substrates, breast cancer resistance protein (BCRP) substrates, or CYP2C9 …
Product Type: Drug
Control Number: 281029
DIN(s): 02559676, 02559684
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-27
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746715804692
… 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant … 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant … 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant …
Product Type: Drug
Control Number: 288071
DIN(s): 02555476, 02555484
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-26
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-14
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722440238663
… use of Verzenio for the adjuvant treatment of Early Breast Cancer (EBC), in addition to the previously approved indication for Advanced /Metastatic Breast Cancer. To support the efficacy, safety and labelling of the … receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on …
Product Type: Drug
Control Number: 249557
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-02-16
Decision / Authorization Date: 2022-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1743434762924
… 2 (HER2)-negative locally advanced or metastatic breast cancer (BC) in Study 1008 (PALOMA-2; median PFS 24.8 vs. …
Product Type: Drug
Control Number: 273901
DIN(s): 02493535, 02493543, 02493551
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751981071024
… retention leading to congestive heart failure, bladder cancer). No safety issues were identified when assessing the …
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-04-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717694387694
… interest for Brukinsa continue to be carcinogenicity (skin cancer), cardiovascular (arrhythmias and hypertension), …
Product Type: Drug
Control Number: 273215
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-10
Decision / Authorization Date: 2024-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718733982360
… 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer following recurrence or progression on or after an … 2 (HER2) negative locally advanced or metastatic breast cancer with one or more AKT1/PTEN/PIK3CA-alterations … or metastatic HR-positive, HER2-negative breast cancer following recurrence or progression on or after an …
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Decision / Authorization Date: 2024-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1715006032208
… Tumour lysis syndrome (TLS), a condition that occurs when cancer cells are killed rapidly, releasing their contents … Canada to treat advanced forms of liver, kidney and thyroid cancers. The safety review was triggered by a labelling … life-threatening condition that can occur during cancer treatment. When cancer cells are killed by the cancer …
DIN(s): 02284227
Issued / Original Publication Date: 2024-05-16
Updated Date: 2024-05-16