Key Points
Nov 16 (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..
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...
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...
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