Pharmacovigilance in Oncology: Managing the Safety of Novel Cancer Therapies

Vani Pathuri

Abstract: Pharmacovigilance in oncology plays a crucial role in ensuring the safety and effectiveness of novel cancer therapies. As new treatments, including immunotherapies, precision oncology, and combination therapies, are rapidly introduced to the market, the need for robust safety monitoring becomes more critical. These therapies often present unique challenges, such as immune-related adverse events (irAEs), long-term safety concerns, and complex interactions between drugs in combination therapies. Effective pharmacovigilance strategies are essential to manage these risks and safeguard patient well-being. This paper will explore the key challenges in oncology pharmacovigilance, including the monitoring of adverse events, the importance of real-world data, and the role of innovative technologies like AI in enhancing safety assessments. We will also discuss the regulatory complexities involved in managing novel cancer therapies and the necessity of balancing efficacy with safety. We propose a multifaceted approach that combines advanced monitoring techniques, real-world data integration, and international collaboration to strengthen oncology pharmacovigilance, ensuring the safe use of cutting-edge cancer therapies.

Keywords: Pharmacovigilance, Vaccine Safety Monitoring, COVID-19 Vaccines, AI in Healthcare, Ethical Considerations in Vaccination