Johnson & Johnson submits New Drug Application for TAR-200 to FDA

USA—American pharmaceutical giant Johnson & Johnson has taken a significant step in cancer treatment by submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TAR-200.

This innovative treatment is designed for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

The application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program.

This program allows the FDA to assess data before formally submitting the application. It aims to speed up the availability of new treatments for patients.

The submission is supported by data from the Phase 2b SunRISe-1 registration study.

Results presented at the European Society for Medical Oncology (ESMO) 2024 Congress showed promising outcomes.

TAR-200 achieved an 83.5% complete response (CR) rate. Importantly, these responses were durable, with 82% of patients maintaining their response after nine months without the need for reinduction.

Safety data, collected up to May 2024, further supports TAR-200’s potential.

The treatment was well-tolerated, with only 9% of patients experiencing severe treatment-related side effects.

Additionally, no treatment-related deaths were reported, and only 6% of patients discontinued due to side effects.

Dr. Yusri Elsayed, Global Therapeutic Head of Oncology at Johnson & Johnson, highlighted the importance of TAR-200 in addressing a critical gap in bladder cancer treatment.

 He explained that many patients currently face radical cystectomy, a surgery involving complete bladder removal, as their only option.

TAR-200 offers a less invasive alternative, combining Johnson & Johnson’s expertise in innovative medicine and medical devices.

TAR-200 is an intravesical drug delivery system that provides sustained, localized release of gemcitabine directly into the bladder.

Healthcare professionals insert the device in a quick outpatient procedure that takes less than five minutes and requires no anaesthesia.

In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD).

This designation recognizes its potential to transform treatment for adults with BCG-unresponsive HR-NMIBC who cannot or choose not to undergo bladder removal surgery.

If approved, TAR-200 could provide new hope for bladder cancer patients with limited treatment options.

Johnson & Johnson remains committed to working with the FDA to bring this promising therapy to market.

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