Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer

23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...

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Health Canada approves Tabrecta: targeted cancer therapy for locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

8 June 2022 - Newest treatment for lung cancer reinforces Novartis commitment to developing innovative therapies that improve outcomes for ...

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The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...

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Health Canada approves Ipsen's Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory or ineligible differentiated thyroid cancer

Pivotal Phase 3 trial data showed Cabometyx demonstrated a significant improvement in progression-free survival. ...

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Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...

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Janssen announces Health Canada approval of Rybrevant (amivantamab), the first and only targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations

4 April 2022 - Targeting both cancer driving and resistance mechanism pathways, Rybrevant offers a unique treatment approach for an ...

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BeiGene announces Health Canada approval for Brukinsa (zanubrutinib) in relapsed or refractory marginal zone lymphoma

3 March 2022 - Third approved indication for Brukinsa in Canada, following mantle cell lymphoma and Waldenström’s macroglobulinaemia. ...

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Health Canada authorises Tecentriq (atezolizumab) for Canadians with early non-small cell lung cancer

4 February 2022 - Tecentriq (atezolizumab) is the first and only cancer immunotherapy approved for non-small cell lung cancer in the ...

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Health Canada authorises Verzenio (abemaciclib) as the first and only CDK4/6 inhibitor for patients with HR+ HER2- high risk early breast cancer

27 January 2022 - Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence ...

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GSK’s Jemperli (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer

15 December 2021 - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial ...

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Health Canada issues Notice of Compliance for Trodelvy, a new treatment option for an aggressive type of metastatic breast cancer

25 November 2021 - Trodelvy significantly reduced the risk of death by 49% compared with single agent chemotherapy in the ...

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Health Canada approves Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)

23 November 2021 - Conditional approval based on data from Phase 3 KEYNOTE-355 trial; introduces first breast cancer indication for ...

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Opdivo receives two new Health Canada approvals

2 November 2021 -  Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for Opdivo (nivolumab).  ...

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Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma

28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...

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New Sarclisa (isatuximab) combination now approved by Health Canada for adults with relapsed and/or refractory multiple myeloma

13 October 2021 - The approval is based on data from the Phase 3 IKEMA trial. ...

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