Health Canada approves Keytruda as monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options

12 September 2024  - Merck announced that Health Canada has granted approval of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy ...

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Padcev (enfortumab vedotin) in combination with pembrolizumab approved by Health Canada to treat advanced bladder cancer

22 August 2024 - Padcev plus pembrolizumab approved based on EV-302 trial. ...

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Health Canada approves Keytruda for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer with no prior systemic therapy for metastatic urothelial cancer, in combination with enfortumab vedotin

22 August 2024 - Approval is based on the Phase 3 KEYNOTE-A39 trial. ...

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Health Canada grants full approval to Jemperli for the treatment of patients with recurrent or advanced dMMR/MSI-H endometrial cancer

24 July 2024 - The conversion of this indication from Notice of Compliance to full approval is based on long term ...

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Health Canada authorizes Alecensaro (alectinib) as the first and only adjuvant treatment for people with ALK positive early stage lung cancer

16 July 2024 - Alecensaro reduced the risk of disease recurrence or death by 76% in people with ALK positive resected ...

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Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer

12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...

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Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations

3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...

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Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test

14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...

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Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy

9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...

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Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women

7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...

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Health Canada authorizes Tecentriq SC (atezolizumab solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types

23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...

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Health Canada approves Keytruda as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy

19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...

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Sumitomo Pharma announces availability of Orgovyx (relugolix) in Canada, the first and only oral androgen deprivation therapy treatment for men with advanced prostate cancer

12 March 2024 - Sumitomo Pharma announced today that Orgovyx (relugolix), an oral gonadotropin-releasing hormone receptor antagonist, is now available for ...

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Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...

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Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1

12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...

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