The Importance of the Accelerated Approval Program: Lilly Oncology’s Perspective

At Lilly Oncology, we are dedicated to developing and delivering innovative new medicines that will make a meaningful difference to cancer patients. Lilly’s research team is leveraging precision medicine and immuno-oncology to bring forth new medicines as fast as possible to help people living with cancer fight their disease. The U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval program, which allows patients earlier access to potentially life-saving medicines when there is a serious need, can play an important role in drug development.

Accelerated Approval regulations, instituted by the FDA in 1992, allow for early approval of promising drugs that treat serious conditions such as cancer. Shaving wait time from the often lengthy FDA approval process can get novel medicine to patients faster – patients who don’t have other treatment options – and provide beneficial, sometimes life-changing therapies. The downside, however, is that despite early promise, there are medications designated by the FDA for Accelerated Approval that don’t, in the end, prove to be as effective as predicted.

Our approach to the ongoing discovery of medicines for people living with cancer is to continue characterizing and building on a strong foundation of existing therapies; developing combinations of medicines that provide maximum results and minimum side effects; prioritizing truly innovative medications; and pursuing partnerships and collaborations that increase options for patients within and across tumor types. We’re committed to the thoughtful use of all available information in this endeavor, including the important tool of Accelerated Approval regulations, and we believe the ongoing evaluation and discussion around consistent requirements for confirmatory trials will greatly benefit physicians and patients. Thank you to the physicians and patients who participate in our many clinical trials worldwide.