Table 4.

Comparison of Time-To-Approval Between RTOR and Non-RTOR NME Oncology Applications Approved in 2020

	Total Applications	Median Approval Time (Range)	Mean Approval Time	Applications with Priority Review	Median Approval Time (Range)	Mean Approval Time	Applications with BTD	Median Approval Time (Range)	Mean Approval Time
RTOR NMEs	5	5 months (4, 8)	6 months	5	5 months (4, 8)	6 months	5	5 months (4, 8)	6 months
Non-RTOR NMEs	11	6 months (5.25, 10)	6.48 months	9	6 months (5.25, 7)	6.03 months	5	5.5 months (5.25, 7)	5.85 months

Under PDUFA VI the review timeline for a standard application is 10 months from the 60-day filing date and 6 months for one with priority review (or 12 months and 8 months, respectively, from the date of submission of the application) [10]

Non-RTOR NMEs include Darzalex Faspro (daratumumab and hyaluronidase-fihj), Gavreto (pralsetinib), Inqovi (decitabine and cedazuridine), Jelmyto (mitomycin hydrogel), Onureg (azacitidine), Pemazyre (pemigatinib), Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf), Retevmo (selpercatinib), Tabrecta (capmatinib), Tazverik (tazemetostat hydrobromide), Zepzelca (lurbinectedin)