Apotex Inc., Canada's largest pharmaceutical company, announced that Health Canada has granted a Notice of Compliance (NOC) for LOQTORZI (toripalimab) for the treatment of nasopharyngeal carcinoma (NPC), described as an ultra-rare and aggressive cancer. This regulatory milestone establishes LOQTORZI as the first and only Health Canada-approved immunotherapy for patients with recurrent unresectable or metastatic nasopharyngeal cancer.
Dual Treatment Indications
The approved therapy offers two distinct treatment pathways for patients with nasopharyngeal carcinoma. LOQTORZI is indicated in combination with cisplatin and gemcitabine for adults with metastatic or recurrent locally advanced NPC. Additionally, the therapy serves as a monotherapy option for adults with recurrent unresectable or metastatic NPC who have progressed following platinum-based chemotherapy.
Strategic Portfolio Expansion
This approval introduces Apotex's first novel biologic therapy, representing a targeted immunotherapy that underscores the company's commitment to expanding access to innovative oncology treatments in Canada. The development marks a strategic evolution of Apotex's portfolio, specifically targeting patients with rare and hard-to-treat cancers. Apotex secured the Canadian rights to LOQTORZI through a licensing agreement with Coherus BioSciences.
"LOQTORZI exemplifies our commitment to Canadian patients and the healthcare system," said Allan Oberman, President & CEO of Apotex. "As the first and only Health Canada-approved immuno-therapy for both the first and later-line treatment of this unique cancer, it delivers a transformative therapy where none previously existed, addressing a critical unmet need."
Clinical Impact and Access
The availability of this immunotherapy represents a significant advancement for patients diagnosed with nasopharyngeal carcinoma, a condition that previously lacked approved immunotherapy options in Canada. Dr. Nathaniel Bouganim, Medical Oncologist and Division Director of Medical Oncology at McGill University Health Centre, emphasized the clinical significance of this development.
"The availability of LOQTORZI in Canada is a meaningful step forward for patients diagnosed with nasopharyngeal carcinoma," Dr. Bouganim stated. "Having this therapy accessible through a Canadian-based pharmaceutical company like Apotex helps promote equitable care for those facing this rare disease."
Regulatory and Safety Information
Health Canada's approval follows standard regulatory review processes for novel biologic therapies. The complete prescribing information, including warnings and precautions, adverse reactions, and contraindications, is available through the product monograph accessible via Health Canada's drug product database.
This regulatory approval aligns with Apotex's broader strategic vision as a Force for Health, expanding the company's presence in pharmaceutical and consumer health products while maintaining focus on improving everyday access to critical medicines for patients across Canada and globally.
