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deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.

Astellas is building off an existing relationship with the biotech formed last August, joining the growing number of large pharmas looking at tackling solid tumors with cell therapy.

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.