Review decisions
Showing 300 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00879
… form of soft tissue sarcoma, a relatively rare subset of cancers arising from mesenchymal cells in the body. GISTs …
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Decision / Authorization Date: 2020-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
… play a minor role (<5%). P‑glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters also …
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00240
… is used for the treatment of certain rare blood cancers, such as primary myelofibrosis and polycythemia … Jakavi (ruxolitinib) is used to treat certain rare blood cancers such as primary myelofibrosis and polycythemia vera. …
Issued / Original Publication Date: 2020-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00587
… epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients should not have received prior … epithelial ovarian, fallopian tube, or primary peritoneal cancer was not proposed for Abevmy. The market authorization … for the following indications: Metastatic Colorectal Cancer Abevmy in combination with fluoropyrimidine-based …
Product Type: Drug
Control Number: 237499
DIN(s): 02522160, 02522179
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-07
Issued / Original Publication Date: 2022-04-21
Decision / Authorization Date: 2021-11-05
Updated Date: 2024-04-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00951
… epidermal growth factor receptor 2 (HER2)-positive breast cancer, including patients with brain metastases, who have … advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have … was the decision issued? Between 15% and 30% of breast cancers overexpress the HER2 receptor and are classified as …
Product Type: Drug
Control Number: 235295
DIN(s): 02499827, 02499835
Manufacturer: Seattle Genetics Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-01-20
Decision / Authorization Date: 2020-06-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00837
… original NDS submission, Control #136842) included breast cancer, uterine bleeding, vascular complications, metabolism … events. Regarding the safety concerns of breast cancer and insertion/removal-related events, it was found … thromboembolic events, cerebrovascular accidents, breast cancer, ectopic pregnancies (on rare occasions), liver …
Product Type: Drug
Control Number: 226314
DIN(s): 02499509
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-28
Decision / Authorization Date: 2020-05-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00905
… locally advanced or metastatic non-small cell lung cancer (NSCLC). Upon review, the recommended and approved … locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received prior treatment with … of patients with ROS1-positive non-small cell lung cancer (NSCLC) - a rare molecularly defined subset of NSCLC …
Product Type: Drug
Control Number: 228159
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-05-31
Decision / Authorization Date: 2020-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00688
… active controlled studies in patients with early breast cancer receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in the neoadjuvant setting. No …
Product Type: Drug
Control Number: 220445
DIN(s): 02497395
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Decision / Authorization Date: 2020-04-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00633
… The following indications for Nivestym are being sought: Cancer patients receiving myelosuppressive chemotherapy: to … and consolidation treatment for acute myeloid leukemia; Cancer patients receiving myeloablative chemotherapy … of neutropenia and neutropenia-related clinical sequelae; Cancer patients undergoing peripheral blood progenitor cell …
Product Type: Drug
Control Number: 214080
DIN(s): 02485575, 02485583, 02485591, 02485656
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-28
Decision / Authorization Date: 2020-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00649
… patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have epidermal growth factor … patients with metastatic non-squamous-non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour …
Product Type: Drug
Control Number: 226905
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-16
Decision / Authorization Date: 2020-04-02