Blog
RSS FeedPosted by Michael Wonder on 27 Mar 2023
Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma
25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...
Posted by Michael Wonder on 25 Nov 2022
Health Canada authorises Polivy (polatuzumab vedotin) for the first-line treatment of adults with large B-cell lymphoma
24 November 2022 - Authorization is based on pivotal data from the Phase 3 POLARIX trial, which met its primary ...
Posted by Michael Wonder on 14 Oct 2022
Health Canada approves Illuccix for prostate cancer imaging
13 October 2022 - Telix Pharmaceuticals announces that Health Canada has approved Illuccix [kit for the preparation of gallium (Ga 68) ...
Posted by Michael Wonder on 13 Oct 2022
Health Canada approves Keytruda (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions
12 October 2022 - Approval based on data from the Phase 3 KEYNOTE-564 trial. ...
Posted by Michael Wonder on 06 Oct 2022
Health Canada approves additional indication for Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer in combination with docetaxel
5 October 2022 - Today's approval was based on the pivotal Phase 3 ARASENS trial, which showed a significant overall survival ...
Posted by Michael Wonder on 14 Sep 2022
Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection
13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...
Posted by Michael Wonder on 08 Sep 2022
Health Canada approves Pluvicto as first targeted radioligand therapy for progressive PSMA positive metastatic castration-resistant prostate cancer
7 September 2022 - Novel mechanism of action of Pluvicto binds to target PSMA positive cancer cells, delivering radiation treatment directly ...
Posted by Michael Wonder on 23 Aug 2022
Health Canada approves Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for adult patients with resectable non-small-cell lung cancer
23 August 2022 - First and only immunotherapy-based treatment for use before surgery for non-small-cell lung cancer in Canada. ...
Posted by Michael Wonder on 11 Aug 2022
Lynparza receives Health Canada approval as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer
11 August 2022 - First and only approved medicine targeting germline BRCA mutations in high-risk early breast cancer. ...
Posted by Michael Wonder on 24 Jun 2022
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 ...
Posted by Michael Wonder on 08 Jun 2022
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 ...
Posted by Michael Wonder on 08 Jun 2022
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 ...
Posted by Michael Wonder on 05 May 2022
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. ...
Posted by Michael Wonder on 19 Apr 2022
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 ...