Becker's Healthcare November 17, 2023
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...
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