Review decisions
Showing 180 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00960
… disease with no effective therapy available once the cancer has spread elsewhere in the body (metastatic UM). The … the immune system to detect and destroy melanoma cancer cells. It has shown a significant survival benefit in …
Product Type: Drug
Control Number: 258717
DIN(s): 02527588
Manufacturer: Immunocore Ireland Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-19
Decision / Authorization Date: 2022-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1703192825535
… for unresectable or metastatic melanoma. Melanoma, a cancer which 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, in 2022, 9,000 Canadians were estimated to …
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Issued / Original Publication Date: 2023-12-21
Decision / Authorization Date: 2023-09-13
Updated Date: 2025-02-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01067
… of such ADRs. For the patients with relapsed or refractory cancers that are described above, there are no standardized …
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
Decision / Authorization Date: 2022-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00942
… or moderate kidney disease, chronic liver disease, current cancer, sickle cell disease or aged ≥ 60 years. Patients …
Product Type: Drug
Control Number: 250151
DIN(s): 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-03-05
Decision / Authorization Date: 2022-04-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687370834165
… antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for … with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated. … antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for …
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-22
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-04-05
Updated Date: 2025-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1682951781384
… organic cation transporter 2, p-glycoprotein, or breast cancer resistance protein). Toxicology The toxicology …
Product Type: Drug
Control Number: 263432
DIN(s): 02533294
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-04-19
Issued / Original Publication Date: 2023-04-13
Decision / Authorization Date: 2022-12-08
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00945
… of adult patients with early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as … patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as … (n=1174) with high-risk, early-stage triple-negative breast cancer (TNBC) received either Keytruda (n=669) or placebo …
Product Type: Drug
Control Number: 256659
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-09-15
Decision / Authorization Date: 2022-04-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1689944674439
… Actinic keratosis is an ultraviolet light-induced precancerous lesion of the skin that represents the initial … squamous cell carcinoma represents 20% to 50% of skin cancers and poses a significant threat due to its ability to … or multiple lesions or as an entire field (known as “field cancerization”). The prevalence of actinic keratoses is high …
Product Type: Drug
Control Number: 262080
DIN(s): 02537818
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-08
Issued / Original Publication Date: 2023-07-20
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00944
… 257236 What was the purpose of this submission? Cervical cancer represents 1.3% of female cancers and 1.1% of female cancer deaths in Canada. In 2021, it was estimated that …
Product Type: Drug
Control Number: 257236
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-01
Decision / Authorization Date: 2022-04-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00938
… (HPV) related oropharyngeal and other head and neck cancers in individuals 9 through 45 years of age. After … 33, 45, 52 and 58 and oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. … against the clinical endpoints of persistent infection, precancerous lesions, and cancers in the anogenital region has …
Product Type: Drug
Control Number: 251509
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-04-07
Decision / Authorization Date: 2022-04-06