Review decisions
Showing 410 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00388
… with hormone receptor (HR)-positive advanced breast cancer instead of the current restriction to patients with … or fulvestrant for the treatment of advanced breast cancer, in combination with letrozole in the first-line … for patients with estrogen receptor (ER)-positive breast cancer. There are no clinical trial data for Ibrance in …
Product Type: Drug
Control Number: 207909
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-07-26
Decision / Authorization Date: 2018-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00450
… as second line maintenance therapy in recurrent ovarian cancer be maintained, regardless of BRCA status, based on … in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in the Second or Later Line Setting ), containing … epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to …
Product Type: Drug
Control Number: 216792
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Issued / Original Publication Date: 2019-11-19
Decision / Authorization Date: 2019-06-27
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00377
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation whose disease has … C (n = 36), who had not been previously treated with anti-cancer therapy and were treated with the combination of …
Product Type: Drug
Control Number: 210753
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00378
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation whose disease has … C (n = 36), who had not been previously treated with anti-cancer therapy and were treated with the combination of …
Product Type: Drug
Control Number: 210760
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-10-30
Decision / Authorization Date: 2018-05-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00399
… for the treatment of adult patients with germline breast cancer susceptibility gene (BRCA)-mutated human epidermal … growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy. Why was the decision issued? Approximately 5% of breast cancers are associated with a mutation in the breast cancer …
Product Type: Drug
Control Number: 210204
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-10-13
Decision / Authorization Date: 2018-05-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00366
… with locally advanced unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following … with unresectable locally advanced non-small cell lung cancer (NSCLC) who had not progressed following … with locally advanced unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following …
Product Type: Drug
Control Number: 208834
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-29
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00398
… patients with platinum-sensitive relapsed (PSR) breast cancer susceptibility gene (BRCA) wild type high-grade … epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to … versus placebo in patients with BRCA wild type ovarian cancer. The link between capsule and tablet is based on …
Product Type: Drug
Control Number: 205344
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-05
Decision / Authorization Date: 2018-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00368
… metastatic or recurrent non squamous non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), platinum-resistant recurrent ovarian cancer, platinum-sensitive recurrent ovarian cancer, and …
Product Type: Drug
Control Number: 201427
DIN(s): 02470748, 02470756
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-29
Decision / Authorization Date: 2018-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00438
… kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have progressed on crizotinib and at … to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The submission was reviewed and considered … kinase (ALK)-positive metastatic non-small cell lung cancer whose disease has progressed on crizotinib and at …
Product Type: Drug
Control Number: 215733
DIN(s): 02485966, 02485974
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-04-26
Issued / Original Publication Date: 2019-07-18
Decision / Authorization Date: 2019-02-22
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00358
… enough patients to detect rare events such as neoplasia (cancer), intracranial hemorrhage or intracranial aneurysm …
Product Type: Drug
Control Number: 205985
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-26
Decision / Authorization Date: 2018-04-25