Dear Dr. Califf:

The undersigned organizations, representing cancer patients, researchers, and providers, are writing to express their appreciation for ongoing efforts to strengthen Food and Drug Administration (FDA) review of cancer products.  The Office of Hematology and Oncology Products has an outstanding record of efficient and effective reviews ensuring patients access to safe and effective cancer treatments without unnecessary delay.  The Office has also given real meaning to “patient-focused” drug development by open and constructive communication with the cancer community regarding cancer drug development and review. 

Despite the stellar record of the Office of Hematology and Oncology Products, the development of therapies that are increasingly targeted and even personalized will require a review approach that is collaborative and cooperative and capitalizes on expertise appropriate for the review of drugs, biologics, and in vitro diagnostics for the diagnosis and treatment of cancer.  We support the establishment of an Oncology Center of Excellence capable of review of cancer drugs, biologics, and in vitro diagnostics, and we commend you for your willingness to consider such a center.

Among the strengths of the Office of Hematology and Oncology Products are reviewers with deep knowledge and experience in oncology, the development and use of new regulatory tools and endpoints, and the sense of urgency that the review teams bring to their work.  These attributes must be incorporated in the Oncology Center of Excellence, and appropriate resources must be made available to ensure that the drugs, biologics, and in vitro diagnostics in the jurisdiction of the Center of Excellence are reviewed in timely fashion.

We also urge that the Oncology Center of Excellence, with appropriate staff and resources, embrace the principles of patient-focused drug development.  This emphasis will ensure that patient needs are considered in all FDA matters, from clinical trial design through product review and approval.

Thank you again for your engagement with the cancer community to enhance cancer drug, biologic, and in vitro diagnostic review.  We look forward to continued collaboration with you and a new Oncology Center of Excellence.

Sincerely,

Cancer Leadership Council

American Cancer Society Cancer Action Network

American Society for Radiation Oncology

Association for Molecular Pathology

CancerCare

Cancer Support Community

Children’s Cause for Cancer Advocacy

Fight Colorectal Cancer

Hematology/Oncology Pharmacy Association

International Myeloma Foundation

Kidney Cancer Association

The Leukemia & Lymphoma Society

LIVESTRONG Foundation

Lymphoma Research Foundation

Multiple Myeloma Research Foundation

National Coalition for Cancer Survivorship

National Comprehensive Cancer Network

National Patient Advocate Foundation

Ovarian Cancer Research Fund Alliance

Prevent Cancer Foundation

Sarcoma Foundation of America

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