J&J's bladder device posts 89% CR
Johnson & Johnson highlighted Phase 1 data for Erda‑iDRS (formerly TAR‑210) showing an 89% complete response and durable remissions at 18 months in intermediate‑ and high‑risk non‑muscle‑invasive bladder cancer. Analysts quickly flagged the results as commercially meaningful — J&J is already expanding into Phase 2/3 studies as it builds oncology optionality beyond surgical devices.
The Phase 1/2 program is registered as NCT05316155 on ClinicalTrials.gov clinicaltrials.gov, with Janssen Research & Development, LLC listed as sponsor, a start date of April 11, 2022, and an estimated primary completion in 2028. Erda‑iDRS is described in investigator materials as an intravesical erdafitinib‑releasing system designed for sustained local delivery over roughly a three‑month dwell time and is inserted using a urinary placement catheter jnjmedicalconnect.com; Janssen acquired an exclusive worldwide license to develop and commercialize erdafitinib from Astex in 2008, per J&J disclosures jnj.com. J&J has already moved TAR‑210/Erda‑iDRS into a multi‑trial pivotal program: MoonRISe‑1 (listed in industry registries as NCT06319820) is a randomized Phase 3 versus investigator‑choice intravesical chemotherapy with about 220 planned patients, and MoonRISe‑3 targets BCG‑treated high‑risk NMIBC as part of the broader MoonRISe program. delta.larvol.com Johnson & Johnson previously commercialized a related intravesical drug‑device, Inlexzo (formerly TAR‑200), which received FDA clearance on Sept. 9, 2025 and whose 2028 sales were modeled at roughly $2.4 billion by a Wall Street note cited in reporting biopharmadive.com.
