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Pink Sheet – US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs

Pink Sheet – US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs

Executive Summary

Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.

The US FDA’s oncology review division is receiving previews of products in development from sponsors, in part so they can understand their goals beyond the next application.


Richard Pazdur, director of FDA’s Oncology Center of Excellence, said the oncology review division is “inviting many of the companies in to present their pipelines.”


For the agency, it appears to be a learning opportunity, rather than a chance to gain a head-start on a review. Pazdur said part of the idea is to help understand the drug sponsors’ endgame, rather than simply work application to application.

“Where are they going with their molecules?” Pazdur said of the pipeline presentations Nov. 14 during the Biopharma Congress, sponsored by Prevision Policy and the Friends of Cancer Research. “And that’s important for our reviewers to hear what they’re ultimate game plan is rather than just getting an NDA or BLA dumped at your door so to speak.”


“I know this is going to cause some heartburn in the industry, but we probably made a decision on your application before you even submitted it,” Pazdur said.

At the same time, within the OCE, Pazdur is encouraging pre-clinical staff to discuss business and development practices with sponsors, such as “what are their molecules that they’re looking at, what are their selection criteria for molecules going forward, why are they doing it, what are they looking at.”


“It’s probably aimed at an earlier interaction with industry than before,” Pazdur added.


FDA also has established robust early interaction systems with sponsors of complex generics (Also see “US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It” – Pink Sheet, 24 Oct, 2017.) and biosimilars (Also see “FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015” – Pink Sheet, 25 Apr, 2016.).

Engagement Critical For Some Companies

Several sponsors apparently have taken advantage of the opportunity to discuss their early stage pipelines with the agency.


Merck & Co. Inc. said it has met with FDA on several occasions to provide “an overview” of its immune-oncology clinical development program. The company also told the Pink Sheet that it regularly communicates with the agency about the progress of clinical programs, “including plans for future trials as well as efficacy and safety updates from existing trials and anticipated submissions.”


“This level of engagement is a critical component of our commitment to move as quickly as possible to bring new options to patients and ensure that our trials meet the highest scientific standards,” a Merck spokesperson said.


Genentech Inc., which is part of Roche, also said that it has had “several conversations with the FDA on our pipeline across disease areas, as well as platforms.”


A Genentech spokesperson would not comment on the details of the meetings, but said they have been worthwhile.


“We value the opportunity to discuss the breadth of our early-stage portfolio with regulatory officials,” the company said.


The meetings, even if only to preview development that is years away from reaching the agency, could be an outgrowth of the success of FDA’s breakthrough therapies program.


Breakthrough is built on the expectation that promising new drugs could gain an expedited path to market through early and frequent interaction with FDA officials. Hundreds of designations were issued during the program’s first five years, many of which resulted in approvals, including several in the oncology space.


The program was so successful that stakeholders have argued that FDA should try to incorporate the lessons beyond program participants. (Also see “PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?” – Pink Sheet, 26 Aug, 2016.)


The idea also seems to fit with Pazdur’s philosophy that his staff function more like an academic institution. He has said that reviewers in many ways discuss health problems just as an academic center. (Also see “FDA Talent Hunt: Better To Recruit From Academia Than Industry?” – Pink Sheet, 14 Dec, 2015.)

Laying Groundwork For Future Approvals

Pipeline meetings also seem to feed into the Office of Hematology and Oncology Products’ policy of encouraging senior leaders and rank-and-file reviewer discussions about applications and their associated issues.The Oncology Center of Excellence was created in part to encourage more collaboration among agency experts in the various product centers. (Also see “FDA’s Pazdur Jumps Over To New ‘Moonshot’ Role” – Pink Sheet, 29 Jun, 2016.)


Pazdur said during the Friends of Cancer Research Annual Meeting on Nov. 15 that oncology reviewers often are discussing applications before they reach the agency, noting the policy is intended to help quality applications gain quicker approvals.


“I know this is going to cause some heartburn in the industry, but we probably made a decision on your application before you even submitted it,” he said.…