Development Of Oncology Therapies: Tips From The FDA To Drive Success

Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer. As our knowledge of oncology science advances and expands, a growing number of malignancy types and subtypes are constantly being identified, breaking down target patient populations into ever-smaller fractions. This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players.

Oncology therapies typically have a comparatively shorter lab-to-clinic turnaround time than therapeutics targeting other diseases. Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies. Biotech companies developing oncology assets thus tend to reach the clinical-stage value inflection point faster than sponsors of other therapies do.