Panel calls on Acrotech, FDA to work together to resolve confirmatory study delay
19 Nov 2023
Drug ApprovalClinical StudyAccelerated ApprovalAcquisition
An advisory panel called on the FDA and Acrotech Biopharma to work together in an effort to generate confirmatory data on the company’s pair of blood cancer treatments sooner than under current timelines. The committee’s acting chairperson Andy Chen said “we would like the FDA and sponsor to strategise about other possible ways to have a shorter study readout than waiting another seven years from now.”
The folate analogue metabolic inhibitor Folotyn (pralatrexate) and HDAC inhibitor Beleodaq (belinostat)HDAC inhibitor Beleodaq (belinostat) were granted accelerated approvals by the agency in 2009 and 2014, respectively, for use as single agents to treat adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). However, Acrotech, a subsidiary of Aurobindo Pharma, only acquired the drugs in 2019 from Spectrum Pharmaceuticals.
Slow enrolment
Both Folotyn and Beleodaq were approved based on objective response rate and duration of response data, with the FDA requiring further studies to verify their clinical benefit. A confirmatory trial, dubbed SPI-BEL-301, was proposed at the end of 2015, with a targeted completion in 2020. However, by April 2019, the study had only enrolled three-quarters of the patients needed.
Having acquired rights to Folotyn and Beleodaq, Acrotech submitted a trial protocol for SPI-BEL-301 to the FDA in 2022. However, the agency raised concerns over dosing in the study, with a final protocol not submitted until January the following year. Under this plan, the trial is not expected to complete until early in 2030, which Chen noted would be “essentially 20 years from the initial approval of [Folotyn].”
Current plan unreasonable
Panellist David Mitchell remarked “I know that the sponsor isn't responsible because [of] the transfer of ownership…but this is a truly remarkable extension of what is intended under the accelerated approval process.” He added that “the current plan to verify clinical benefit is not reasonable, giving the proposed timelines and the risks to which we are subjecting patients and potentially causing harm.”
Many members of the committee also called for changes to the study design and population, so that results would be available sooner. Christopher Lieu said “I actually have significant concerns about the feasibility of the confirmatory study,” adding “I would strongly recommend a faster study in a refractory setting to avoid potentially harming patients for an additional seven years.” Panel member Gita Thanarajasingam agreed that the confirmatory trial should be “a smaller study in the relapse refractory setting to get an earlier readout.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.