Health Canada approves Elahere for certain types of platinum-resistant ovarian cancers

2 September 2025 - Elahere received approval through Health Canada's priority review process, based on data from the pivotal MIRASOL Phase ...

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Health Canada approves dual immunotherapy Opdivo plus Yervoy for colorectal and liver cancers

19 August 2025 - Bristol Myers Squibb Canada today announced that Health Canada has approved Opdivo (nivolumab) in combination with ...

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Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma

18 August 2025 -  Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...

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Health Canada approves Keytruda for patients with resectable locally advanced head & neck squamous cell carcinoma tumours that are PD-L1 (CPS) positive as neo-adjuvant treatment, continued as adjuvant treatment combined with radiotherapy with or without cisplatin then as monotherapy

13 August 2025 - Approval is based on KEYNOTE-689 Phase III clinical trial results. ...

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Imfinzi approved in Canada as first and only peri-operative immunotherapy for muscle invasive bladder cancer

6 August 2025 -  Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab) for the treatment of patients ...

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Health Canada expands approval of Scemblix, making it an option for newly diagnosed and previously treated chronic myeloid leukaemia patients

30 July 2025 - Scemblix is first to show superior efficacy and a favourable safety and tolerability profile in a Phase ...

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Xtandi (enzalutamide) now funded in Ontario for all approved prostate cancer indications

26 June 2025 - Today, Astellas Pharma Canada announced that Xtandi (enzalutamide) is now funded by the Ontario Drug Benefit Program ...

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Health Canada approves Novartis' Kisqali for HR positive, HER2 negative early breast cancer patients at high risk of recurrence

18 June 2025 - Health Canada approval is based on the pivotal Phase 3 NATALEE trial data, which demonstrated a clinically ...

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Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML

16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...

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Enhertu (trastuzumab deruxtecan) receives time limited reimbursement recommendation from Canada's Drug Agency for gastric cancer

23 May 2025 - AstraZeneca and Daiichi Sankyo are pleased to announce that Canada's Drug Agency has issued a time-limited reimbursement ...

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New subcutaneous formulation of Opdivo approved in Canada for use across all authorised solid tumour indications

27 May 2025 - Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden. ...

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Tagrisso approved (with conditions) in Canada for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer

21 May 2025 - Based on LAURA Phase 3 trial results which showed patients who took Targrisso after CRT had ...

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Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma

22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...

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Health Canada approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma

22 April 2025 - Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial. ...

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Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients

17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...

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