Review decisions
Showing 20 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766085611036
… of adult patients with FIGO 2014 Stage III–IVA cervical cancer . This submission was filed under the Notice of … in participants with high-risk locally advanced cervical cancer. Patients were randomized (1:1) to receive either … with FIGO 2014 Stage III–IVA locally advanced cervical cancer (LACC) when used in combination with concurrent …
Product Type: Drug
Control Number: 284571
DIN(s): 02456869
Manufacturer: Merck Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-01
Decision / Authorization Date: 2025-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768243878335
… advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Upon review of the submitted data package, … advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) was provided in TRIDENT-1, a Phase 1/2, …
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Decision / Authorization Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769626224845
… advanced, unresectable stage III non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor … advanced, unresectable Stage III non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R point …
Product Type: Drug
Control Number: 288417
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-07-11
Decision / Authorization Date: 2025-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769177568104
… 2 (HER2)-negative, locally advanced or metastatic breast cancer following recurrence on or within 12 months of … HER2-negative, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant … 2 (HER2)-negative, locally advanced or metastatic breast cancer following recurrence on or within 12 months of …
Product Type: Drug
Control Number: 288071
DIN(s): 02555476, 02555484
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-26
Decision / Authorization Date: 2025-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1762956369249
… for sale in Canada for the treatment of various blood cancers. In addition, Imbruvica specifically can be used for …
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02491788, 02512963, 02535696, 02540215, 02554267, 02562006, 02562014
Issued / Original Publication Date: 2025-11-26
Updated Date: 2025-11-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765901981864
… treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease had not progressed following … of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following …
Product Type: Drug
Control Number: 290251
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-09
Decision / Authorization Date: 2025-04-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762525671043
… from the AK indication and to add the term “and/or field cancerization” to the Dosage and Administration section of … lesions but also multiple lesions or areas of field cancerization. Based on the evidence provided, the … also proposed the addition of the term “and/or field cancerization” to the Dosage and Administration section to …
Product Type: Drug
Control Number: 262828
DIN(s): 02323273
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764698444664
… the treatment of adult patients with metastatic colorectal cancer (mCRC) who had previously received treatment or were … with BSC in adult patients with metastatic colorectal cancer (mCRC) who had progressed on or were intolerant to …
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Decision / Authorization Date: 2024-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763666918420
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) … advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition … locally advanced or metastatic non-small cell lung cancer (NSCLC) in the pivotal study A2201 (GEOMETRY mono-1). …
Product Type: Drug
Control Number: 255972
DIN(s): 02527391
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-08-20
Decision / Authorization Date: 2022-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764950755465
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor … (EGFRm; Ex19del and/or L858R) non-small cell lung cancer (NSCLC), who had not received any prior therapy for …
Product Type: Drug
Control Number: 279138
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-09-15
Decision / Authorization Date: 2024-07-10