FDA red and green lights: June 2025

There were six US oncology approvals in June, and a couple of these were contentious. The most unexpected was the thumbs up for UroGen’s Zusduri in low-grade intermediate-risk non-muscle invasive bladder cancer, despite an earlier knockback from an FDA advisory committee.

Also somewhat controversial was the accelerated nod for AstraZeneca and Daiichi’s TROP2-targeting ADC Datroway in second-line EGFR-mutated NSCLC, a setting with unclear scientific backing. Meanwhile, Keytruda got another notch on its belt with approval in perioperative PD-L1-positive head and neck cancer, while Nuvation beat its ROS1 inhibitor rival Nuvalent to the market with the go ahead for Ibtrozi.

The approvals were rounded out by green lights for new uses of Bayer’s prostate cancer drug Nubeqa and Incyte’s CD19-targeting MAb Monjuvi.

Datroway doubts

It was second time lucky for Datroway in NSCLC – Astra and Daiichi had previously hoped for approval in second-line non-squamous disease, but were forced to pull their filing in November.

The accelerated approval was based on a 45% overall response rate among 114 patients with EGFR mutations in the Tropion-Lung05 and Tropion-Lung01 trials. It will need to be confirmed by Tropion-Lung15, testing Datroway with or without Tagrisso, versus chemo, in second-line EGFR-mutated NSCLC.

One question is why a patient whose cancer is still driven by EGFR would respond to TROP2 inhibition, and why this approach might be preferred versus a next-generation EGFR inhibitor, for example. In any case, first-line NSCLC is the bigger opportunity, and the partners should see results soon from the phase 3 Avanzar trial.

Datroway is also approved in second-line ER-positive, HER2-negative breast cancer.

UroGen yes

UroGen was criticised for not running a randomised trial of Zusduri (then known as UGN-102) by an FDA panel, which voted 4-5 vote against the drug’s benefit/risk. But in the end this didn’t stop approval or even delay the drug, which got the nod a day before its PDUFA date.

Urogen’s stock rocketed in the wake of the FDA yes, but it will now have to launch the drug itself.

In the ROS1 inhibitor race, Nuvation gained full approval for Ibtrozi in ROS1-mutant NSCLC regardless of therapy line, despite the drug being backed only by uncontrolled ORR data, and one of its supporting studies, Trust-I, being carried out entirely in China.

Nuvalent’s rival project zidesamtinib is a potential threat, with a US filing is due soon, but this will only be in lung cancer patients relapsed after treatment with earlier-generation tyrosine kinase inhibitors.

Meanwhile, Incyte looks to have got the better end of a bargain that saw it pick up Monjuvi as part of Novartis’s purchase of that drug’s originator, Morphosys. Incyte paid just $25m for full Monjuvi rights, while Novartis has been hit with delays for pelabresib, the driver of its €2.7bn takeout.

Monjuvi, which sold $119m in 2024, will now add a full follicular lymphoma approval to its existing accelerated nod in relapsed/refractory DLBCL. In the latter setting, data from the confirmatory B-Mind trial appear to have been delayed; results had been expected in 2024, but there has been no word as yet. An even bigger prize would be first-line DLBCL, where the Frontmind trial is due to yield data this year.

Selected June 2025 US regulatory decisions in oncology

Note: CSPC=castration-sensitive prostate cancer; NMIBC=non-muscle invasive bladder cancer; NSCLC=non-small cell lung cancer. Source: OncologyPipeline.