Review decisions
Showing 170 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00543
… include relevant caveat statements): Metastatic Colorectal Cancer Zirabev in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See Drug-Drug Interactions section of the Zirabev … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Zirabev, in combination with carboplatin/paclitaxel …
Product Type: Drug
Control Number: 217524
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-06-22
Issued / Original Publication Date: 2021-07-21
Decision / Authorization Date: 2021-01-05
Updated Date: 2024-03-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00433
… designed to deliver cytotoxic levels of radiation to cancer cells that overexpress specific receptors. The …
Product Type: Drug
Control Number: 217184
DIN(s): 02484552
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-18
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2019-01-09
Updated Date: 2024-03-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00441
… is also an inhibitor of P-glycoprotein (P-gp), Breast Cancer Resistance Protein (BCRP), organic anion transporter … favorable-risk status according to National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2015). … for therapeutics indicated for the treatment of advanced cancer. Non-clinical pharmacology Enasidenib targets the …
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Issued / Original Publication Date: 2019-08-19
Decision / Authorization Date: 2019-02-06
Updated Date: 2024-06-13
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/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/SBD00445
… of Verzenio as maintenance therapy in Early Breast Cancer (EBC) with the removal of the Ki-67 score as a … receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on … receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on …
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-05
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00447
… locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor … locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor … locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor …
Product Type: Drug
Control Number: 214572
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-03-16
Issued / Original Publication Date: 2019-10-22
Decision / Authorization Date: 2019-02-26
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00457
… by a qualified physician experienced in the use of anticancer therapies. Furthermore, it specifies that concomitant … by a qualified physician experienced in the use of anticancer therapies. Furthermore, it specifies that concomitant … Acalabrutinib was a substrate for P-glycoprotein and breast cancer resistance protein in vitro. Safety pharmacology …
Product Type: Drug
Control Number: 214504
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-03-15
Issued / Original Publication Date: 2020-01-13
Decision / Authorization Date: 2019-08-23
Updated Date: 2025-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00486
… use in the treatment of the following patient populations: Cancer patients receiving myelosuppressive chemotherapy … Nivestym is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer patients receiving myeloablative chemotherapy …
Product Type: Drug
Control Number: 214080
DIN(s): 02485575, 02485583, 02485591, 02485656
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-02-28
Issued / Original Publication Date: 2020-07-30
Decision / Authorization Date: 2020-04-16
Updated Date: 2024-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00380
… stromal cells and its signalling pathway is important in cancer cell proliferation, metastasis, and the tumour … sarcomas account for only approximately 0.7% to 1.0% of all cancers and approximately 2% of all cancer-related deaths. In Canada (based on the most recent …
Product Type: Drug
Control Number: 203478
DIN(s): 02469227
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-02-09
Updated Date: 2021-11-12