OCE Improvements Suggested
The American Association for Cancer Research says it has four recommendations in response to the FDA 3/15 public meeting on the structure and function of the Oncology Center of Excellence (OCE). The comment letter says (1) OCE should have clear, final signoff authority for all product reviews associated with anti-cancer therapeutics; (2) all Office of Hematology and Oncology Products staff and any other oncology-focused staff from CBER and CDRH should be brought under OCE; (3) patient engagement should remain a priority; and (4) OCE should continue to maintain its high level of integrity in review processes while continuing to support innovation and approvals that deliver safe and effective cancer drugs to patients in a timely manner.
In its comments, AstraZeneca recommends that (1) OCE be the single and final regulatory decision-making body for all cancer treatment products within FDA; (2) OCE should be staffed with personnel with the requisite scientific, technical expertise to facilitate focused, streamlined, and integrated multidisciplinary product-based reviews; (3) review personnel with relevant scientific, technical expertise across CDER, CBER, and CDRH should be brought together within OCE to facilitate formation of integrated multidisciplinary product-based review teams; (4) adequate budget along with all other resources to facilitate staffing of integrated multidisciplinary product review teams within OCE should be provided; and (5) review of all cancer treatment products should be consolidated within OCE to facilitate streamlined, integrated product reviews.
The Society of Nuclear Medicine and Molecular Imaging says the concept of theranostics is rapidly developing with agents that are highly targeted molecular entities that can be used for both nuclear medicine imaging and therapy depending on the radionuclide attached. “Currently, there are two separate sections of FDA that will have to consider and approve the NDAs for these agents,” it says. “Because of the mutual dependence of the agents on one another, it would be far more appropriate and efficient if there were a mechanism where the two NDAs would be paired and would be considered simultaneously by the same group at FDA…. Such an approach would likely significantly shorten the time to approval and would make these agents available to patients much sooner.”
The American Society of Clinical Oncology says OCE should continue to build upon successes of CDER and other Centers to develop an integrated regulatory approach for anti-cancer therapeutics and diagnostic products used in the selection or delivery of cancer treatment. “For this to succeed,” it says, “it is important that OCE has clear, final sign-off authority for all product reviews associated with anti-cancer therapeutics.” The group also echoes the idea that all Office of Hematology and Oncology Products staff become OCE staff, saying such a move would eliminate any ambiguity about which staff and division is overseeing the regulation and development of oncology and hematology products.
Finally, Accelerate Brain Cancer Cure et al forwards a 2016 letter sent by 28 stakeholder groups supporting creation of OCE and outlining ways in which it could successfully operate.