Review decisions
Showing 570 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00278
… among both sexes in percent distribution of estimated new cancer cases in Canada in 2015. Approximately 20% of … melanoma include cytotoxic chemotherapies, the targeted cancer therapies of Zelboraf (vemurafenib) monotherapy, … by a qualified physician experienced in the use of anti-cancer agents. A Risk Management Plan (RMP) for Cotellic was …
Product Type: Drug
Control Number: 182788
DIN(s): 02452340
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-12
Issued / Original Publication Date: 2016-03-30
Decision / Authorization Date: 2016-02-22
Updated Date: 2025-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00036
… used in adult patients to treat an aggressive type of skin cancer (unresectable or metastatic melanoma). It works by … Use in Canada ZELBORAF slows down or stops the growth of cancer cells by targeting specific proteins. ZELBORAF is … used in adult patients to treat an aggressive type of skin cancer (unresectable or metastatic melanoma) that has a …
Issued / Original Publication Date: 2015-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00287
… expanded to allow use in male patients with advanced breast cancer. The submission was reviewed and considered … with hormone receptor (HR)-positive advanced breast cancer instead of the current restriction to patients with … of women with ER-positive, HER2-neative advanced breast cancer who had not received any prior systemic anticancer …
Product Type: Drug
Control Number: 182048
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-02-12
Issued / Original Publication Date: 2016-05-19
Decision / Authorization Date: 2016-03-16
Updated Date: 2025-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00207
… Acute lymphoblastic leukemia (ALL) is a rare aggressive cancer of the blood and bone marrow. Adult patients who … lymphoblastic leukemia (ALL) is a rapidly growing type of cancer in which the bone marrow makes too many B-cell … bearing a specific TCR, or on peptide antigens presented by cancer cells. Blinatumomab mediates the formation of a …
Product Type: Drug
Control Number: 181723
DIN(s): 02450283
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-01-30
Issued / Original Publication Date: 2016-01-26
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00040
… the current available information on the potential risk of cancer associated with PROLIA (denosumab). This review was … requirements. In that report, Health Canada noted cases of cancer. Therefore, Health Canada requested that the manufacturer submit a summary report on all cases of cancer associated with the use of PROLIA for further …
Issued / Original Publication Date: 2015-01-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00044
… receptor inhibitors are used for treating various types of cancer. The type of cancer treated varies with each specific VEGF receptor … inhibitors work by slowing down the growth and spread of cancer cells by cutting off the blood supply that keeps …
Issued / Original Publication Date: 2015-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00249
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety … for Harvoni related to hepatocellular carcinoma (liver cancer). NC # 212676 2018-01-09 Issued NOL 2018-04-16 …
Product Type: Drug
Control Number: 173180
DIN(s): 02432226
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-01-12
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00209
… therapy in adult patients with unresectable hepatocellular cancer with a caveat that efficacy and safety data for … radioactive iodine-refractory differentiated thyroid cancer. 1 What was approved? Lenvima, an antineoplastic … radioactive iodine-refractory differentiated thyroid cancer. Of 261 patients who received Lenvima in a pivotal …
Product Type: Drug
Control Number: 180877
DIN(s): 02450291, 02450305, 02450313, 02450321, 02468220, 02468239, 02484056, 02484129
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-01-08
Issued / Original Publication Date: 2016-02-09
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00293
… (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The submission was reviewed and considered … of adult patients with resectable non-small cell lung cancer (NSCLC) (tumors ≥4 cm or node positive). The … nivolumab for patients with metastatic non-small cell lung cancer (NSCLC) expressing programmed death‑ligand 1 (PD-L1) …
Product Type: Drug
Control Number: 180828
DIN(s): 02446626, 02446634, 02557320
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-12-19
Issued / Original Publication Date: 2016-01-08
Decision / Authorization Date: 2015-09-25
Updated Date: 2026-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00267
… to rule out a clinically meaningful increase in colorectal cancer risk above an estimated background risk in a suitable …
Product Type: Drug
Control Number: 180223
DIN(s): 02445727
Manufacturer: NPS Pharma Holdings Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-12-09
Issued / Original Publication Date: 2015-11-09
Decision / Authorization Date: 2015-09-04
Updated Date: 2023-04-11