Regulatory Perspectives of Approval of Novel Cancer Therapies

Abstract

The abstract section gives a brief of the entire study at a glance as below. newlineBackground: newlineCancer is a major cause of death and a major impediment to extending life expectancy. It newlinehas been predicted by GLOBOCAN 2020 that the total number of new cases of all types newlineof cancer among both the sexes in India may rise from 1.32 million in 2020 to 2.09 million in 2040. There are still some cancers for which there are no effective treatments, including pancreatic cancer, liver cancer, and certain forms of brain tumours in adults and children. newlineThis is the case even with the tremendous advances in cancer treatment that have occurred in recent years. Furthermore, far too many cancer patients who receive appropriate therapy suffer long-term side effects from the disease and its management, such as an increased risk of recurrent cancer. Many new and innovative approaches to slow the spread of cancer have been devised, and many more are constantly being worked on. newlineOncological research is constantly attempting to create innovative, cost-effective newlinetreatments for cancer that have less harmful side effects than conventional therapy. newlineHowever, these medications face a myriad of challenges, including technological, preclinical, clinical, manufacturing, etc. leading to regulatory approval delays or failures. newlineThe approval probability of new anti-cancer medications ranges between 60-80% newlineencompassing both, Europe and United States of America. The major factors affecting newlinethis process are the experience of the companies in the drug development procedure and the high regulatory approval demands. The approval process of anticancer drugs is newlineusually slower than other drugs. Thus, identification of the challenges or factors affecting the regulatory approval process is essential. The present research aims to perform the extensive study on the challenges encountered and recommendations for the development of the novel cancer therapies, study/comparison on regulatory guidelines across the globe.