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RSS FeedPosted by Michael Wonder on 17 Jan 2025
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 ...
Posted by Michael Wonder on 14 Jan 2025
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 ...
Posted by Michael Wonder on 10 Jan 2025
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. ...
Posted by Michael Wonder on 30 Nov 2024
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 ...
Posted by Michael Wonder on 23 Oct 2024
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. ...
Posted by Michael Wonder on 07 Oct 2024
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 ...
Posted by Michael Wonder on 13 Sep 2024
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 ...
Posted by Michael Wonder on 25 Aug 2024
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. ...
Posted by Michael Wonder on 25 Aug 2024
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. ...
Posted by Michael Wonder on 25 Jul 2024
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 ...
Posted by Michael Wonder on 17 Jul 2024
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 ...
Posted by Michael Wonder on 13 Jul 2024
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 ...
Posted by Michael Wonder on 04 Jul 2024
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, ...
Posted by Michael Wonder on 17 May 2024
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 ...
Posted by Michael Wonder on 11 May 2024
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. ...