Pharmacovigilance of anti-cancer medicines: opportunities and challenges.

Introduction: The foundations of pharmacovigilance are the monitoring of drug safety in real-world medicine, and identification of new adverse effects, unknown at the time of market approval. Cancer patients are prone to adverse drug reactions due to the complexity of the neoplastic disease and its treatment. Pharmacovigilance of anti-cancer medicines is further complicated because patients have comorbidities, as for elderly patients.

Safety Profiles and Pharmacovigilance Considerations for Recently Patented Anticancer Drugs: Lung Cancer.

Background: Lung cancer is the most frequent cause of cancer-related death. In the last decades, the introduction of targeted therapies and more recently, of immunotherapy, has led to significant improvements in different outcomes of this malignant neoplasm.

Objective: The present review provides a balanced overview of most recent targeted therapies and immunotherapies patented for the treatment of lung cancer.

An Update of Efficacy and Safety of Cetuximab in Metastatic Colorectal Cancer: A Narrative Review.

Colorectal cancer is the second most common cancer, representing 13% of all diagnosed cancers. Cetuximab is a recombinant chimeric monoclonal IgG1 antibody and epidermal growth factor receptor (EGFR) inhibitor. Cetuximab is approved for the first-line treatment in combination with chemotherapy or as a single agent in patients who have failed or are intolerant to chemotherapy in patients with EGFR-expressing, RAS wild-type metastatic colorectal cancer.

EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies.

An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicochemical characteristics, efficacy, and safety to an original biological drug already approved in the European Union, for which marketing exclusivity rights have expired. Generally, the safety monitoring of biosimilars follows the same requirements that apply to all biologicals, even if specific pharmacovigilance measures exist and some of them are still being debated.

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology.

The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects).