Tags : Health Canada

Biosimilars Regulatory

Apobiologix’s Bambevi (biosimilar, bevacizumab) Receives Health Canada Approval for Multiple

Shots: Apobiologix expands its footprints in Canada with the approval of Bambevi + CT to treat colorectal, lung, brain and ovarian cancer The approval is coupled with well-established Apobiologix supportive care products that enable the company to transform access to affordable therapies in oncology and other indications In 2016, Apobiologix launched its first product, Grastofil […]Read More

Regulatory

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated

Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, […]Read More

Regulatory

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval

Shots: The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis The study showed higher hematologic response rate in ITT population (53% vs 18%), patients […]Read More