AB Science has received approval from the European Medicines Agency (EMA) to extend the shelf life of its veterinary cancer medicine MASIVET from 36 months to 48 months. The extension applies specifically to the 50mg tablet strength of MASIVET currently available throughout the European Union.
Treatment Indication and Mechanism
MASIVET is approved for treating non-resectable mast cell tumors in dogs, specifically Grade 2 or 3 tumors with confirmed mutations in the c-kit tyrosine kinase receptor. The drug represents a targeted therapy approach for canine oncology, focusing on specific molecular pathways involved in tumor development and progression.
Clinical and Practical Impact
The shelf-life extension provides significant practical benefits for veterinary cancer care. According to AB Science, this regulatory change offers patients, caregivers, and the company greater flexibility in adjusting inventory levels to meet current and future demand while reducing the risk of product expiration.
The extended shelf life ensures continuity of treatment access across all EU countries where MASIVET is currently marketed. This development supports veterinarians in maintaining consistent treatment availability for their canine cancer patients, addressing a critical need in veterinary oncology where treatment interruptions can significantly impact patient outcomes.
Regulatory Significance
The EMA's approval of the shelf-life extension reflects the agency's confidence in the drug's stability profile over the extended storage period. This type of regulatory approval requires comprehensive stability data demonstrating that the drug maintains its potency, safety, and quality characteristics throughout the extended shelf life.
For veterinary practices and distributors, the longer shelf life reduces inventory management challenges and potential waste from expired products, ultimately supporting more efficient distribution of this specialized cancer treatment across the European market.
