An FDA panel is urging Acrotech Biopharma to accelerate research into the efficacy of two blood cancer drugs brought to market via the agency's accelerated approval pathway.
The FDA's Oncologic Drugs Advisory Committee met Nov. 16 to discuss the drugs, Folotyn and Beleodaq, which were approved in 2009 and 2014, respectively. The accelerated approval program is intended to grant patients quicker access to life-saving drugs and requires drugmakers to conduct follow-up studies to confirm the drug's efficacy. However, the pathway has evolved into a prevalent method for drugmakers to secure approvals without undergoing extensive and costly large-scale trials, according to Bloomberg.
About one-third of 187 cancer drugs approved via the accelerated pathway still have outstanding studies to prove their clinical benefits. Studies for Folotyn and Beleodaq are among those with the most delays. Records show the study deadline for Folotyn, which costs about $900,000 a year, has been postponed at least 10 times, according to Bloomberg.
Acrotech, which acquired the drugs from another company in 2019, said studies for both drugs won't be completed until 2030.
The drugmaker did not respond to Bloomberg's request for comment but said it is committed to promptly completing the required studies in hearing documents cited by the publication. The company attributed the "unanticipated delays" to several factors, including slow study enrollment and COVID-19-related disruptions.