Review decisions
Showing 360 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00523
… patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumour aberrations, and … treatment for metastatic non-squamous non-small cell lung cancer. A Notice of Compliance (NOC) was recommended and … patients with metastatic non-squamous non-small cell lung cancer who received one of three treatment regimens, 2 new …
Product Type: Drug
Control Number: 217324
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-06-15
Decision / Authorization Date: 2019-05-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00469
… the intended use of Xospata in patients with advanced cancer, there are no pharmacological or toxicological issues …
Product Type: Drug
Control Number: 227918
DIN(s): 02495058
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-05-22
Issued / Original Publication Date: 2020-03-23
Decision / Authorization Date: 2019-12-23
Updated Date: 2025-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00551
… identified in the NON included risks of endometrial cancer, breast cancer and stroke.. Review of the information provided in … R-NON regarding the safety risks of breast and endometrial cancers, and supported by clinical experience and active …
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Decision / Authorization Date: 2019-05-10
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/RDS00521
… uses currently held by Herceptin in Canada: early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Why was the decision issued? The …
Product Type: Drug
Control Number: 204579
DIN(s): 02474425, 02474433
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-18
Decision / Authorization Date: 2019-05-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00222
… device used to treat the effects on skin of a type of cancer of the immune system (cutaneous T-cell lymphoma) … in Canada used to treat the effects on skin of a type of cancer of the immune system (cutaneous T-cell lymphoma) … in Canada to treat the skin manifestation of a type of cancer of the immune system (cutaneous T-cell lymphoma) that …
Issued / Original Publication Date: 2019-05-03
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/RDS00553
… censoring rules (i.e. not censoring for start of a new anticancer therapy or 2 or more missed assessments) did not … by the European Association of Urology and the Kidney Cancer Research Network of Canada. Experts contacted by …
Product Type: Drug
Control Number: 208710
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-08-24
Decision / Authorization Date: 2019-04-23