FDA red and green lights: July 2025

July saw some notable oncology approvals, but also a couple of rejections, of which the complete response letter for Replimune’s oncolytic virus vusolimogene oderparepvec was especially surprising. Replimune's rival Iovance got the nod for its tumour infiltrating lymphocyte therapy Amtagvi in the same post-PD-(L)1 melanoma population, based on data from an uncontrolled trial that produced similar results to Ignyte, the Replimune trial deemed inadequate by the FDA.

Roche’s knockback for its CD20-targeting T-cell engager Columvi in second-line DLBCL, meanwhile, was widely expected after a harsh FDA advisory committee meeting, but at least the group avoided the worst-case scenario of having to pull the drug from the market.

Roche looks likely to have a second chance at confirming and expanding Columvi’s current accelerated approval in third-line DLBCL. It hopes to use the first-line Skyglo trial, although it will have to hope that it doesn’t run into the same problems as in the second-line Starglo study, which was lambasted for not enrolling enough US patients – with Americans also doing particularly badly.

For their part, Replimune investors might hope that the shock departure of Vinay Prasad as head of CBER, after only a few months in the job, will herald a reversal in fortunes. Prasad was seen as a possible reason for the FDA’s strict stance on vuso-vec, after being relatively lenient with other advanced therapies. Indeed, Replimune’s stock jumped 100% on Wednesday, the day after Prasad left the FDA, but is still well below its pre-CRL levels.

Regeneron

Regeneron had good news in early July, with approval for its first T-cell engager – a field the group has been trying to break into for some time. The BCMA-targeting Lynozyfic was previously rejected over third-party manufacturing issues, but got the accelerated nod second time around, in fifth-line multiple myeloma.

The company hopes to catch up with its rivals, Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio, helped by apparently better efficacy and convenience. But the multiple myeloma market is evolving, with Car-T moving into earlier lines, and J&J also taking aim at the precursor disorder, smouldering disease, with Darzalex.

Regeneron is still awaiting a separate verdict on its CD20-targeting T-cell engager odronextamab, a potential competitor to the aforementioned Columvi. A decision had been expected by 30 July, but hadn't come as the month ended.

Odronextamab was knocked back by the FDA in March 2024, with Regeneron citing insufficient enrolment into its confirmatory trials. The group had previously hoped to get the go ahead in both DLBCL and the more indolent follicular lymphoma, but it refiled only in follicular disease. Toxicity has always been a worry with odronextamab, and a delay could be seen as bad news for the project.

Finally, Dizal secured its first US approval, for Zegfrovy in second-line NSCLC with EGFR exon 20 insertions. However, there are questions over whether this will ever reach US patients, as Dizal has no presence in this country.

Selected July 2025 US regulatory decisions in oncology

Note: *on 1 August Regeneron disclosed that odronextamab had received a CRL on 30 July. Source: OncologyPipeline.