FDA's accelerated approval for listing: 14 items of K drugs have been converted into full approval for a maximum of 8 years

In vernacular According to evaluatepharma, in 2019, FDA approved 14 new drug applications (including first application and supplementary application) through accelerated approval, less than 18 in 2018 Accelerated approval is a regulatory approach that allows FDA to accelerate the approval of major disease drugs through alternative endpoints or intermediate clinical endpoints, rather than just directly measuring clinical benefits According to the data released by FDA, the drugs approved through acceleration are mainly anti-cancer drugs, especially this year For example, keytruda has so far obtained 14 approvals through alternative endpoints, four of which have been converted to full approvals Of course, it can also be seen from the figure above that few newly approved drugs can be converted into full approval, but the real concern is that some drugs that have been on the market for many years still fail to be converted into full approval, which means that these drugs still lack sufficient data support On October 29, 2019, the FDA expert group voted 9:7 to support the withdrawal of Makena, a drug for premature delivery, which was approved by the FDA in February 2011, but two phase III studies have failed since its launch In April 2019, lartruvo, Lilly's new advanced soft tissue sarcoma drug, chose to withdraw from the market globally due to poor data of large-scale phase III research after its launch It is also noteworthy that keytruda failed in clinical trials of liver cancer and gastric cancer last year, respectively, but the FDA has yet to say whether to cancel the accelerated approval of these two indications Evaluatepharma also made statistics on the time to convert accelerated approval to full approval As shown in the top corner of the figure below is tykerb, GSK's breast cancer drug It took more than 8 years for GSK to convert the new indication of accelerated approval obtained in 2010 into full approval.