Review decisions
Showing 100 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00611
… Guidelines) and international (National Comprehensive Cancer Network Clinical Practice Guidelines) treatment … or expressed at high frequency on the surface of cancer cells. Poteligeo targets and binds to CCR4, enhancing …
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-31
Issued / Original Publication Date: 2022-10-25
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00580
… (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy. The … instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment … instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment …
Product Type: Drug
Control Number: 251105
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-03-26
Issued / Original Publication Date: 2022-03-09
Decision / Authorization Date: 2021-12-23
Updated Date: 2024-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00567
… increased susceptibility to opportunistic infections and cancer. A cumulative total of 84,409 HIV cases have been … with inhibitors of CYP3A4, P-glycoprotein (P-gp), or breast cancer resistance protein (BCRP) may increase temsavir …
Product Type: Drug
Control Number: 250213
DIN(s): 02520869
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-03-05
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-10-01
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00537
… heart disease, chronic kidney disease, type 2 diabetes, cancer, and pulmonary obstructive disease. In addition, the … based on investigator’s assessment. Examples include: cancer treatment, bone marrow or organ transplantation, …
Product Type: Drug
Control Number: 249830
DIN(s): 02516691, 02516705
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-02-24
Issued / Original Publication Date: 2021-07-07
Decision / Authorization Date: 2021-06-09
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00565
… 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have receive endocrine-based therapy and at least … reports based on the metastatic triple-negative breast cancer target population. The submission was reviewed and … locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior …
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-01-25
Issued / Original Publication Date: 2021-12-23
Decision / Authorization Date: 2021-09-24
Updated Date: 2024-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic …
Product Type: Drug
Control Number: 248435
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00599
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). NC # … disease or confirmation of PET‑positive disease after anticancer therapy for disease control as determined by an … Patients were able to receive bridging chemotherapy (anticancer treatment) while waiting for their cells to be …
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-17
Issued / Original Publication Date: 2022-08-16
Decision / Authorization Date: 2022-05-06
Updated Date: 2024-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00566
… provided the final report for the small cell lung cancer cohort from study B-005 (PM1183-B-005-15). The … adult patients with Stage III or metastatic small cell lung cancer who have progressed on or after platinum-containing … adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after …
Product Type: Drug
Control Number: 247485
DIN(s): 02520834
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-16
Issued / Original Publication Date: 2022-01-04
Decision / Authorization Date: 2021-09-29
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00574
… include relevant caveat statements): Metastatic Colorectal Cancer Aybintio, in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See the Drug-Drug Interactions section of the … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Aybintio, in combination with a …
Product Type: Drug
Control Number: 247369, 247724
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-11
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-11-30
Updated Date: 2024-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00624
… with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom prostate-specific membrane antigen … tomography of PSMA-positive lesions in men with prostate cancer: with suspected metastasis who are suitable for … antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are suitable for …
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US), Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-06
Issued / Original Publication Date: 2023-02-03
Decision / Authorization Date: 2022-10-13
Updated Date: 2025-02-05