Review decisions

Showing 120 results of 342 total
Summary Basis of Decision for Gavreto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00559
… advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). A validated test is required prior to … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). A validated test is required prior to … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). Gavreto was authorized under the Notice of …
Product Type: Drug
Control Number: 243731
DIN(s): 02517590
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-26
Decision / Authorization Date: 2021-06-30
Updated Date: 2025-06-04
Summary Basis of Decision for Retevmo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749640931774
… is favourable for the treatment of the following cancers that harbour genetic alterations in the rearranged … ) gene: metastatic RET fusion-positive non-small cell lung cancer in adult patients, RET -mutant medullary thyroid cancer in adult and pediatric patients 12 years of age and …
Product Type: Drug
Control Number: 243748
DIN(s): 02516918, 02516926
Manufacturer: Loxo Oncology, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-09
Decision / Authorization Date: 2021-06-15
Updated Date: 2025-06-04
Summary Basis of Decision for Pemazyre
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00576
… The 5-year survival rate by the American Joint Committee on Cancer stage is 50% for Stage I, 30% for Stage II, 10% for … and signaling and selectively decreases cell viability in cancer cell lines with activating FGFR genetic alterations, … and signaling, and selectively decreases cell viability in cancer cell lines with activating FGFR genetic alterations, …
Product Type: Drug
Control Number: 242569
DIN(s): 02519933, 02519941, 02519968
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2022-02-16
Decision / Authorization Date: 2021-09-17
Updated Date: 2024-06-07
Summary Basis of Decision for Koselugo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00618
… with neurofibromatosis type 1include gliomas, breast cancer, leukemia, pheochromocytomas, and gastrointestinal … in neurofibromatosis type 1 syndrome and different types of cancers. The market authorization of Koselugo was based on … within 3 to 6 months), based on the United States National Cancer Institute (NCI) central review. The target plexiform …
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-08-31
Updated Date: 2024-11-22
Summary Basis of Decision for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00542
… Waldenström’s macroglobulinemia (WM) is a rare form of cancer that begins in the white blood cells. An estimated … by a qualified physician experienced in the use of anticancer therapies, and highlights the risk of serious … by a qualified physician experienced in the use of anticancer therapies, and highlights the risk of serious …
Product Type: Drug
Control Number: 242748
DIN(s): 02512963, 02554267
Manufacturer: Beigene Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-08-12
Issued / Original Publication Date: 2021-07-15
Decision / Authorization Date: 2021-03-01
Updated Date: 2026-02-23
Summary Basis of Decision for Odomzo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00490
Product Type: Drug
Control Number: 229407
DIN(s): 02500337
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-08-11
Updated Date: 2022-11-09
Summary Basis of Decision for Tepmetko
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00554
… for the treatment of patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations who are … advanced unresectable or metastatic non-small cell lung cancer harbouring mesenchymal-epithelial transition tyrosine … advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition …
Product Type: Drug
Control Number: 242300
DIN(s): 02516322
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-10-21
Decision / Authorization Date: 2021-05-27
Updated Date: 2024-09-05
Summary Basis of Decision for Evrysdi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00544
… risdiplam. Additionally, risdiplam is a substrate of breast cancer resistance protein (BCRP) and may be a substrate of …
Product Type: Drug
Control Number: 242373
DIN(s): 02514931
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-07-27
Decision / Authorization Date: 2021-04-14
Updated Date: 2025-07-11
Summary Basis of Decision for Enhertu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00539
… or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of … Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer … with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based …
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-24
Issued / Original Publication Date: 2021-07-09
Decision / Authorization Date: 2021-04-15
Updated Date: 2025-05-30
Summary Basis of Decision for Verquvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
… play a minor role (<5%). P‑glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters also …
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-02

Displaying 111 - 120 of 342 | Page 12 of 35
Date modified: