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# ODAC Looking at Long Delays in 2 Acrotech Trials
- URL: https://www.fdaweb.com/odac-looking-at-long-delays-in-2-acrotech-trials/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155786

FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to consider at its 11/16 meeting the lengthy delays Acrotech Biopharma is experiencing in completing confirmatory post-marketing requirement trials for its Folotyn (pralatrexate) and Beleodaq (belinostat). An agency [briefing document](https://www.fda.gov/media/173781/download?ref=fdaweb.com) circulated before the meeting says the drugs were granted accelerated approval, Folotyn in 2009 and Beleodaq in 2014, as single agents to treat adults with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). “The clinical benefit has not yet been verified for either drug,” it says.

The briefing document presents the agency’s position and the sponsor’s position on several issues around the delayed confirmatory trials. In it, FDA says there have been substantial delays in the conduct of the confirmatory trial and other post-marketing requirements. “Dosing concerns, toxicities, and inadequate dose optimization for both drugs have necessitated further dose optimization efforts before initiation of the confirmatory Phase 3 portion of this trial,” the agency says. “The final protocol was submitted to FDA after an eight-year delay, and the final report for the confirmatory trial is not projected to be submitted until 2030, resulting in a total period of uncertainty of clinical benefit of at least 21 years for pralatrexate and at least 16 years for belinostat.”

The document says FDA is convening the ODAC meeting “to provide an update on the accelerated approval program in oncology, with respect to these two NDAs … that have not met their agreed-upon milestones for completion of confirmatory trials.”

Acrotech tells the committee it has completed several of the post-market requirements other than the confirmatory trial, and says the drugs have shown an “encouraging trend of success” in the first-line setting and they are the only FDA-approved drugs for their indication. “The sponsor is committed to fulfilling the post-marketing requirement by conducting a Phase 3 study in the most expeditious manner,” it says.

FDA acknowledges the drugs have clinically meaningful activity and says that given the limited options available for patients with their indication, the agency does not advocate for withdrawing the accelerated approval. “However,” it says, “due diligence should be executed to ensure that therapies made available to patients with R/R PTCL verify clinical benefit, limiting the time a patient may be exposed to a potentially unsafe or ineffective therapy.”

Committee members are asked to discuss:

- the delays in post-approval confirmatory trials for the drugs and whether the plan to verify their clinical benefit is reasonable considering the proposed timelines; and
- strategies to promote timely completion of the confirmatory trial post-marketing requirements for the drugs, and insights from this experience that may facilitate the completion of confirmatory trials for future accelerated approvals.