Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Iovance’s Amtagvi won FDA accelerated approval in February, and Adaptimmune’s afami-cel may not be far behind, but cell therapies for solid tumors come with some extra challenges.

The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.