FDA panel urges Acrotech to speed up study on cancer drugs

[November 17, 2023]  (Reuters) - A panel of independent experts to the U.S. health regulator urged Acrotech Biopharma to work with the agency to bring forward the date for releasing trial data that could confirm benefits of the company's blood cancer drugs.

The drugs, Folotyn and Beleodaq, have already been on the market for nearly a decade or more. They were approved under the U.S. Food and Drug Administration's accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer.

That type of approval requires the company to conduct a study to show that the drug actually works.

"We would like the FDA and sponsor to strategize about other possible ways to have a shorter study readout than waiting another seven years from now," the panel's acting chairperson Andy Chen said on Thursday.

The company's final study plan was submitted to the FDA in 2022 and is expected to be completed by 2030, according to FDA briefing documents published earlier this week.

Acrotech, a unit of India's Aurobindo Pharma, plans to evaluate the drugs in combination with a widely used chemotherapy regime.

The panel's agenda did not include discussion around revoking accelerated approvals for the drugs, and some members of the panel were divided about whether Acrotech's plan for confirmatory study was reasonable.

FDA staffer David Mitchell said at the meeting that the current study timeline poses risk to patients and could cause them harm.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The FDA last year raised issues with Acrotech's proposed dosing in a confirmatory trial for the drugs.

Acrotech changed the design of its study to divide it into two parts: one determining the optimal doses of the drugs and a second evaluating the efficacy and safety of the drug combinations and comparing them with a widely used chemotherapy regimen alone.

New Jersey-based Acrotech has said it remains committed to fulfilling the requirements for its drugs in a timely manner.

Pralatrexate, or Folotyn, and belinostat, or Beleodaq, are used for treating patients with a rare and aggressive type of blood cancer known as peripheral T-cell lymphoma, which develops in mature white blood cells and natural killer cells.

Both the drugs are used to treat patients whose cancer has relapsed or stopped responding to other treatments.

(Reporting by Bhanvi Satija in Bengaluru; Editing by Shinjini Ganguli and Shounak Dasgupta)

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