The two FDA pilot programs—Real-Time Oncology Review and Assessment Aid sped up the processing of Novartis’s supplemental new drug applications for Kisqali (ribociclib), said Samit Hirawat, executive vice president and head of Global Oncology at Novartis.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
