Review decisions
Showing 150 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00485
… locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received prior treatment with … clinical benefit. Tropomyosin receptor kinase (TRK) fusion cancer is defined by a specific type of genetic mutation … and survival, promoting the development of TRK fusion cancer. Current estimates indicate that an NTRK gene fusion …
Product Type: Drug
Control Number: 227517
DIN(s): 02495007, 02495015
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-05-08
Issued / Original Publication Date: 2020-07-16
Decision / Authorization Date: 2020-02-10
Updated Date: 2025-06-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00475
… inhibitor; the substrates of CYP 3A4, P-gp, and breast cancer resistance protein (BCRP), or the neuraminidase …
Product Type: Drug
Control Number: 227361
DIN(s): 02496364, 02496372, 02524163
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-30
Issued / Original Publication Date: 2020-05-05
Decision / Authorization Date: 2020-02-19
Updated Date: 2023-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00472
… ranks as the second most common cause of death, after cancer. In the last few decades, there have been major …
Product Type: Drug
Control Number: 227235
DIN(s): 02495244
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-04-29
Issued / Original Publication Date: 2020-04-27
Decision / Authorization Date: 2019-12-30
Updated Date: 2024-10-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00481
… increased susceptibility to opportunistic infections and cancer. Additionally, HIV‑1 infection contributes to …
Product Type: Drug
Control Number: 227315
DIN(s): 02497204, 02497220, 02497247
Manufacturer: ViiV Healthcare ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-29
Issued / Original Publication Date: 2020-06-12
Decision / Authorization Date: 2020-03-18
Updated Date: 2025-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00493
… PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an … PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an … PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an …
Product Type: Drug
Control Number: 226941
DIN(s): 02497042, 02497069, 02497077, 02497085
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-17
Issued / Original Publication Date: 2020-08-27
Decision / Authorization Date: 2020-03-11
Updated Date: 2025-08-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00488
… the reference biologic drug in female patients with breast cancer receiving established myelosuppressive chemotherapy. … Both studies were conducted in female patients with breast cancer receiving established myelosuppressive chemotherapy. … between Ziextenzo and EU‑Neulasta in patients with breast cancer. Treatment with any therapeutic protein is naturally …
Product Type: Drug
Control Number: 220445
DIN(s): 02497395
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Issued / Original Publication Date: 2020-07-31
Decision / Authorization Date: 0020-04-21
Updated Date: 2024-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00482
… of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. The submission … patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa has not been studied in patients … patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa has not been studied in patients …
Product Type: Drug
Control Number: 226146
DIN(s): 02496348
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-06-29
Decision / Authorization Date: 2020-02-20
Updated Date: 2025-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00483
… leukemia is a heterogeneous group of aggressive blood cancers, characterized by increased blast counts, … biological processes and is disrupted in various types of cancer. A pivotal Phase Ib/II study, BRIGHT AML 1003 … of biological processes and disrupted in various types of cancer. Glasdegib binds to Smoothened (SMO), a transmembrane …
Product Type: Drug
Control Number: 225793
DIN(s): 02498472, 02498480
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-15
Issued / Original Publication Date: 2020-07-10
Decision / Authorization Date: 2020-04-28
Updated Date: 2025-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00459
… renal pelvis to the urethra. It accounts for 90% of bladder cancer. Bladder cancer is the fifth most common malignancy in Canada, with … 15% to 20% of locally advanced or metastatic urothelial cancers. The medicinal ingredient in Balversa, erdafitinib, …
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-02-08
Issued / Original Publication Date: 2020-01-28
Decision / Authorization Date: 2019-10-25
Updated Date: 2025-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00551
… intravenous antibiotics), malignancies (non-melanoma skin cancers and melanoma skin cancers), and major adverse cardiovascular events. Based on … intravenous antibiotics), malignancies (non-melanoma skin cancers and melanoma skin cancers), and major adverse …
Product Type: Drug
Control Number: 224036
DIN(s): 02516098
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-01-25
Issued / Original Publication Date: 2021-09-15
Decision / Authorization Date: 2021-05-19
Updated Date: 2023-10-11