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Pink Sheet – US FDA's Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say

Pink Sheet – US FDA's Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say

Executive Summary

CDER’s OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.


A restructuring of staff within the US FDA to strengthen the Oncology Center of Excellence (OCE) is one of the primary changes that advocates want to see in the agency’s intercenter institute.


At an OCE listening session March 15, several external stakeholders commented to FDA staff that they would like to see all Office of Hematology and Oncology Products (OHOP) staff from the Center for Drug Evaluation and Research (CDER) be moved into OCE. The recommendation was one of many from audience members about how they would like would like the OCE structured and the function it should serve as an intercenter institute. 


“This complete transition would eliminate any ambiguity about which staff and division is overseeing the regulation and development of oncology products,” Richard Schilsky, senior vice president and chief medical officer of the American Society for Clinical Oncology (ASCO), said of an OHOP transition.


Schilsky further called for OCE to continue OHOP’s organization of “different disease groups with integrated, multi-disciplinary teams.”


“This approach enhances integration of expertise about the clinical presentation, natural history and therapeutic approaches to cancer with expertise about the biological mechanisms that drive cancer initiation, progression and response or resistance to treatment,” Schilsky said.


Friends of Cancer Research Founder and Chair Ellen Sigal also endorsed transitioning OHOP staff to OCE.


Both Sigal and Schilsky also supported OCE having the review and final sign-off authority for all drugs, biologics and devices for the treatment of cancer. This would entail also shifting relevant staff from the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) to OCE, the two said. Schilsky specifically mentioned CBER experts in areas such as cellular and gene therapy for cancer, and CDRH experts in in-vitro diagnostics and therapeutic devices.


Currently, OCE oversees all clinical reviews for oncology therapies, but the underlying application still goes to the traditional center, which conducts the non-clinical aspects of the review and retains sign-off authority. (Also see “Oncology In 21st Century Cures: Heading Toward A Two-FDA Solution?” – Pink Sheet, 10 Jan, 2017.)


“The evaluation of products that are used by cancer patients has to be done by cancer experts who understand the disease, the needs of a patient, the context in which a product is being used,” Schilsky said. “And I think the guiding principle is if product is intended for cancer use, it should be under OCE, along with the corresponding experts who evaluate that product.”


Sigal added that shifting the relevant staff to OCE from the other centers would “add consistency and synchrony to the review of cancer treatments.”


OCE made its debut in January 2017, after the 21st Century Cures Act was passed with a provision requiring the agency to create cross-center groupings to better coordinate its handling of major diseases. (Also see “Cures Bill Authorizes ‘Intercenter Institutes,’ But Will US FDA Create Them?” – Pink Sheet, 28 Nov, 2016.)


FDA Commissioner Scott Gottlieb has discussed setting up additional centers of excellence in the fields of immunology and neuroscience, with OCE’s finalized structure serving as a template. (Also see “US FDA May Create Immunology, Neuroscience Centers Of Excellence” – Pink Sheet, 1 Dec, 2017.)


However, he admitted there have been issues fully setting up OCE as a result of insufficient funding, and that the agency would need to fix those issues before moving on to other therapeutic areas. (Also see “Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says” – Pink Sheet, 7 Dec, 2017.)


Nevertheless, FDA officials have spoken highly of the work OCE has done so far at the agency. CBER Director Peter Marks has said that OCE played an important role in the clinical review of the three gene therapies approved in the US. (Also see “RMAT Designation, Gene Therapies Highlight 2017 CBER Transformation” – Pink Sheet, 17 Jan, 2018.)


In 2017, OCE conducted the clinical review for 12 new drugs and new biologics for the treatment of cancer, as well as one medical device.


Tamy Kim, associate director for regulatory affairs for OHOP and OCE, noted at the listening session that the agency’s intercenter institute has provided subject matter and regulatory expertise on more than a dozen submissions for breakthrough designation, as well as 100 key development meetings. OCE additionally has conducted outreach with patient advocacy groups and oncology organizations through workshops and symposia, Kim added. 

Direction, More Transparency Needed

Sigal was particularly vocal about what she felt was a lack of direction regarding OCE.


“We have no clear understanding of the organizational plan, processes or timelines for achieving milestones for setting up the OCE,” Sigal said. “Cancer patients cannot afford logistical delays, and the OCE was not established to add another level of bureaucracy.


“The external stakeholders and community would benefit from understanding how the OCE will be organized, how it will be staffed, how it will function in relation to the typical product reviews, and the timelines will be met.”


Sigal asked the panel of FDA officials at the listening session whether the public would be able to look at and comment on the proposed structure of OCE once it is finalized.


OCE Director Rick Pazdur responded that FDA is having “active discussions” about what a final structure of the center may look like, and that the agency wants community input.


“I will take your concerns back to Dr. Gottlieb,” Pazdur said. “But ultimately he is the person that will have to make the decision on what the eventual course of OCE will be.”


Jeff Allen, president and CEO of Friends of Cancer Research, called for OCE to publish an orgaizational chart outlining its structure, noting that he could not find one on FDA’s website.


Allen also noted other aspects he would like to see that would make OCE a success, such as a publicized budget. A budget, Allen said, “would be very useful for us to be able to move forward with to understand where resources are needed and how they would be applied.”


He additionally called for the publication of annual metrics.


“We know from our work that the oncology activities of FDA lead the world,” Allen said. “To hear that annually, to be able to make their case in terms of meeting timeframes, products approved, processes used, external activities, are very helpful.”

Praise From Merck

Scott Korn, vice president for global regulatory affairs for oncology at Merck & Co. Inc., had nothing but good things to say about OCE’s work so far.


“Our view is that this past year, OCE has been very successful in its primary goals of expediting development of oncology drug products using an integrated approach, facilitating communication and knowledge-sharing with various stakeholders, and embarking on new and needed regulatory initiatives,” Korn said.


Korn noted that Merck has had several interactions with OCE about policy issues and the drugmaker’s early- and late-stage oncology programs, including for its PD-1 inhibitor Keytruda (pembrolizumab).


“These interactions have been uniformly collaborative and informative, and we appreciate the perspective OCE brings to these discussions,” Korn said. We believe the cross-center, integrated approach under OCE has been beneficial in expediting drug development for novel oncology products, which patients need.”…