J&J says Inlexzo follow-up 'promising' in bladder cancer

Johnson & Johnson has revealed early clinical data with a new formulation of its FGFR inhibitor erdafitinib that suggests it could become the first targeted treatment for early‑stage bladder cancer.

Phase 1 results of Erda-iDRS (formerly TAR-210) – which uses a drug delivery technology that allows it to be administered directly into the bladder – revealed an 89% complete response rate after 18 months in patients with intermediate‑risk non-muscle-invasive bladder cancer (NMIBC) whose tumours carry FGFR mutations, with a "tolerable safety profile," according to the drugmaker.

FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70% of intermediate-risk and 40% of high-risk NMIBC cases. J&J said it is now running a comprehensive phase 2 and 3 trials programme for Erda-iDRS, which provides three months of exposure to erdafitinib and could sidestep some of the side effects seen with oral dosing of the drug.

J&J sells erdafitinib under the Balversa brand name, a product that was first approved in 2019 and is used to treat advanced, FGFR-positive bladder cancer. Sales are currently not broken out in J&J's financial updates – some sources estimate a current run rate of around $60 million a year – but extension of the drug's use into early-stage bladder cancer would allow it to target a much larger patient population.

Erda-iDRS is a follow-up to J&J's Inlexzo (formerly TAR-200), which was approved in the US last September and uses the same technology to deliver gemcitabine chemotherapy directly into the bladder. The FDA approved Inlexzo for NMIBC that does not respond to BCG, a live bacterial vaccine that is currently the standard first-line treatment for this type of cancer.

Inlexzo was highlighted in Clarivate's annual round-up of Drugs to Watch this year, with analysts predicting it could make G7 sales of $1.8 billion in five years as a monotherapy and in combination with other drugs like checkpoint inhibitors, despite competition from rivals like ImmunityBio's Anktiva (nogapendekin alfa inbakicep) and Ferring Pharma's Adstiladrin (nadofaragene firadenovec).

J&J acquired rights to Inlexzo and Erda-iDRS when it bought privately-owned biotech Taris for an undisclosed sum in 2019, and has big sales expectations for the franchise, predicting that combined sales of the two products could reach $5 billion if both reach the market.

"Intermediate-risk [NMIBC] is defined by recurrences, and many patients undergo repeated procedures as their tumours return," said Antoni Vilaseca Cabo of the Hospital Clínic de Barcelona in Spain, who presented the phase 1 results at the European Association of Urology (EAU) 2026 annual congress.

"In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time," he added.

"Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention."

J&J's trials programme for Erda-iDRS includes the phase 3 MoonRISe-1 study in intermediate-risk NMIBC in the adjuvant setting, after surgery to remove the tumour, and the phase 2 MoonRISe-2 study to see if patients can be treated without surgery.

MoonRISe-3 is looking at the treatment in patients with high-risk papillary NMIBC who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.

Photo by Tim Mossholder on Unsplash