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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Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer

10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...

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Health Canada approves Keytruda for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, in combination with carboplatin and paclitaxel and then continued as monotherapy

19 March 2025 - Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 trial. ...

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Health Canada authorises Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer

10 March 2025 - Phase 3 MARIPOSA study showed Lazcluze plus Rybrevant significantly improved progression-free survival, reducing the risk of ...

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Health Canada authorizes Itovebi (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2 negative breast cancer with a PIK3CA mutation

19 February 2025 - The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the ...

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Health Canada approves Merck's Keytruda (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

11 February 2025 - Approval is based on the Phase 3 KEYNOTE-671 trial. ...

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Albertan with rare blood cancer calls on Health Canada to approve life-saving drug

20 January 2025 - An Alberta woman living with a rare form of blood cancer is calling on Health Canada ...

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Takeda's Fruzaqla (fruquintinib) receives Health Canada market authorisation for metastatic colorectal cancer

20 January 2025 - Positive reimbursement recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux. ...

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Long wait for cancer drug approvals causing 'great anguish' among patients, doctors

18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...

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Rybrevant plus chemotherapy approved in Canada as first and only targeted treatment to reduce risk of disease progression or death by more than half in second-line EGFR mutated advanced lung cancer

16 January 2025 - Phase 3 MARIPOSA-2 study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival compared ...

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CAR T cell therapy Breyanzi (lisocabtagene maraleucel) approved for second-line relapsed or refractory diffuse large B-cell lymphoma

13 January 2024 - In the pivotal Phase 3 TRANSFORM trial, Breyanzi demonstrated a significant improvement in event-free survival over ...

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Astellas receives Health Canada approval for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer

9 January 2024 - Canada's Drug Agency recently issued draft recommendation to reimburse Vyloy with conditions. ...

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Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...

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Health Canada approves first and only oral targeted treatment for brain cancer

22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...

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Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA targeted therapy

4 October 2024 - Telix Pharmaceuticals today announces that Health Canada has approved the use of Illuccix (kit for the ...

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