Shots:Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative optionsApproval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
Shots:Health Canada has approved label expansion for Ixchiq against CHIKV disease in individuals (≥12yrs.)Approval was based on a P-III trial of Ixchiq vs PBO in adolescents over 6mos., which showed a superior high & sustained immune response in 99.1% of participants; data was published in The Lancet Infectious DiseasesAdditionally, label extension filing…
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 ±…
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 LancetInterim analysis of the ongoing OLE…
Shots:Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapyApproval 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, respectivelyDREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…
Shots:Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancerApproval 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…
Shots:Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26NDS 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…
Shots:Health Canada has approved Omvoh to treat mod. to sev. active Crohn’s disease (CD) unresponsive/intolerant to conventional or biologic therapy along with its new citrate-free formulation for SC use in both UC & CDApproval was based on P-III (VIVID-1) trial of Omvoh (900mg, IV, wks.0, 4, 8 then 300mg, SC, Q4W from wks.12-52;…
Shots:Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFHApproval 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…
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:…

