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Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots:  Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs) Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean; data was published in The Lancet Interim analysis of the ongoing OLE…
August 11, 2025

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GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…
July 24, 2025

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Merck new
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Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Shots: Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancer Approval was based on P-III (KEYNOTE-A18/ ENGOT-cx11/GOG-3047) trial assessing Keytruda (200mg, IV, Q3W × 5 cycles) + CRT followed by Keytruda (400mg, IV, Q6W × 15 cycles) vs PBO + CRT in 1060 pts with…
July 22, 2025

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Bavarian Nordic
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Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Shots: Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26 NDS was based on 2 P-III trials (n>3,500) that met their 1EP, with 97.8% of subjects aged 12–64yrs. & 87.3% aged >65yrs. developing neutralizing antibodies by day 21 post vaccination; seroresponse rates…
July 22, 2025

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Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots: Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFH Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…
July 15, 2025

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Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)   

Shots:  Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials  Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization  Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)  Ref: PRNewsWire | Image:…
July 2, 2025

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Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

Shots: Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025 Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity. YESAFILI is a…
June 27, 2025

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