CLINICAL DEVELOPMENT IN ONCOLOGY
Project Optimus: helping or hindering cancer drug development?
Experts say that Project Optimus is a necessary reform in the oncology space, but one that should be applied with caution.
JUSTINE RA
The purpose of Project Optimus is to reform the dose optimisation and dose selection paradigm for cancer drug development. Credit: ESB Professional via
Shutterstock.com.
A
longside the multitude of guidance documents, recent years have seen the US Food and Drug Administration
(FDA) ramp up workshops and project implementation efforts in a bid to drive innovation in drug development. Agency eyes have zeroed in on oncology, with the FDA Oncology Center of Excellence (OCE) introducing frameworks such as Project Optimus to reform the dose optimisation and dose selection paradigm in oncology drug development. While the framework of Optimus is not new
to drug development, it is relatively new to oncology. In non-deadly indications, researchers have been employing the framework for quite some time because the
chances of patient survival are higher, making drug toxicity less acceptable in these indications compared to a high-morbidity indication such as cancer, says Dr Fouad Namouni, president of research & development at Blueprint Medicines. The philosophy of oncology drug
development—both academically and in pharma—is to save patient lives. However, development has historically prioritised drug efficacy and eliminating tumours and cancer at the expense of increased treatment toxicities. This can be seen across several therapies such as chemotherapy, small molecules, antibodies, and cell and gene therapies, most of which have a positive impact on efficacy and patient survival but come at the cost of toxicities.
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