January 2017 Edition Vol.12, Issue 1

2017 Forecast Series—Amy McKee, MD, Acting Deputy Director, CDER’s Office of Hematology and Oncology Products, Comments on the FDA Oncology Center of Excellence

OBR talked to Amy McKee, MD, Acting Deputy Director, of the FDA’s Center for Drug Evaluation and Research (CDER), Office of Hematology and Oncology Products (OHOP), about how oncology drug development is evolving to achieve quicker oncology drug approvals, and also got her thoughts on the new FDA Oncology Center of Excellence (OCE) and its goals.

OBR: Can you discuss how the model for oncology clinical drug development is evolving? How do the FDA’s “breakthrough therapy” and “accelerated approval” programs factor in, and in your opinion, has it worked?

AM: Please see the perspective article published in the New England Journal of Medicine on seamless trial design.

Seamless drug trials are intended to obtain information on drug dosing, activity, and efficacy in one trial and avoid the delays of conducting separate phase 1, 2, and 3 trials. It is a more fluid approach that allows expansion cohorts to be added after the early dose-finding phase of the trial to, for example, investigate activity in different diseases or to start examining various biomarkers to define which populations are most likely to respond to the drug. Adopting this approach complements FDA’s expedited regulatory programs such as breakthrough designation and accelerated approval to get new therapies to patients in the most efficient manner possible.

OBR: How does the agency balance the risk-benefit of oncology drugs and patient safety with quicker drug development and accelerated approvals?  

AM: The standards for regulatory marketing approval are unaffected by expedited programs such as accelerated approval. A risk-benefit assessment for the specific product in the specific disease setting is determined based on the data submitted and the context of the treatment setting for the specific disease.

OBR: The FDA Oncology Center of Excellence (OCE) is a new endeavor. Tell us about the integrated approach that the OCE is using, and how it will speed the review process. What are the long-term goals?

AM: The OCE will leverage the oncology and regulatory expertise across the FDA to ensure the best and most innovative approaches to this complicated disease area. Ultimately, the OCE will continue the mission of the FDA – to promote and protect the health of the American public.

OBR: How do you expect the cancer patient’s voice be integrated into the mission of the Oncology Center of Excellence to help drive progress in the prevention, diagnosis, and treatment of cancer?

AM: The Office of Hematology and Oncology Products (OHOP) continues to engage patients and their advocacy groups in drug development and identify opportunities for research and collaboration focusing on patient-reported outcomes to inform regulatory policy. We plan to expand existing patient-focused drug development efforts and foster collaboration among FDA Centers, external stakeholders involved in cancer research, and cancer patient advocates.

Our organizational structure emphasizes our commitment to this effort, including leadership at the Office level and clinical and statistical leads responsible for inclusion of the patient voice in drug development through clinical outcome assessment review. We are also recruiting to expand internal expertise in patient reported outcomes and other clinical measures, such as investigating the utility of data from wearable devices.

OBR: Some drug companies weren’t fully transparent with the public as to their interaction with the FDA concerning cancer drugs in 2016. For example, the FDA told Spectrum not to seek approval for its bladder cancer drug, which the company failed to disclose. Does the agency have any plans to remedy situations like these?

AM: The Agency is prohibited by law from disclosing any information to the public about Investigational New Drug applications or marketing applications such as New Drug Applications (NDAs) or Biologics Licensing Applications (BLAs) except in the context of an advisory committee meeting. Furthermore, the FDA does not have any authority to force companies to disclose any communications between the Agency and the company during product development.

Update: About the same time that this interview was published, the FDA announced the establishment of the Oncology Center of Excellence (OCE) and the appointment of Dr. Richard Pazdur as its director.  Read the release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537564.htm

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