Tags : Health Canada

Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as adjuvant therapy in people with HER2+ eBC with pathological residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant taxane and Herceptin-based treatment The P-III KATHERINE study results: reduction in the risk of residual invasive BC recurrence or death […]Read More

AstraZeneca Canada’s Calquence (acalabrutinib) Receives Health Canada Approval for Patients

Shots: The NOC is based on the positive data of Calquence in ACE-LY-004 trial demonstrating 81% OR rate for patients with relapsed or refractory MCL The Health Canada approval of Calquence allows AstraZeneca to develop the treatments of blood cancers Calquence (acalabrutinib, previously known as ACP-196) is an oral selective inhibitor of Bruton’s tyrosine kinase (BTK) […]Read More

The US FDA Initiates its First Step Towards Project Orbis

Shots: The US FDA announces Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) providing a framework concurrent submission and review of oncology therapies in collaboration with TGA and Health Canada, allowing for simultaneous decisions in all three countries The collaboration allows cancer patients to receive earlier access to products in other […]Read More

Teva Canada’s Herzuma (biosimilar, trastuzumab) Receives Health Canada Approval for

Shots: Health Canada has granted notice of compliance for Teva Canada’s Herzuma for the treatment of early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) in Canada The Health Canada NOC is based on efficacy, safety, quality, immunogenicity, PK/PD data from non-clinical and clinical studies, demonstrating that Herzuma and Herceptin has […]Read More