A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.

The US FDA has approved supplements for 17 drugs, as well as four new molecular entities and novel biologics, under the Real-Time Oncology Review pilot since the program launched in February 2018.

The RTOR program has produced exceedingly quick review times in some cases. Seattle Genetics, Inc.’s Adcetris (brentuximab vedotin) holds...

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