Oncology center director Pazdur thinks it is time to streamline the expedited pathways for drug development in the US. Focusing on the goals, rather than the paperwork, is a good idea – but is easier said than done.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Approximately 25% of patients in the TIVO-3 trial had prior treatment with checkpoint inhibitors, but progression-free survival in this subgroup was similar to the overall population, giving the FDA confidence about tivozanib's role in contemporary treatment regimens, Drug Review Profile finds.

After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.