US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for TAR-200. The drug is intended for use in 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 tumors. The FDA is expected to review the submission through the Real-Time Oncology Review (RTOR) program, allowing for data review before the complete application is formally submitted.
TAR-200: Innovative Drug Delivery System
TAR-200 is an innovative intravesical drug-releasing system designed to provide sustained local delivery of gemcitabine into the bladder. The system is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia. This approach offers a convenient and effective method for delivering targeted therapy to patients with HR-NMIBC.
FDA Breakthrough Therapy Designation
The drug was awarded Breakthrough Therapy Designation (BTD) by the FDA in December 2023 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. This designation highlights the potential of TAR-200 to address significant unmet medical needs in this patient population.
Clinical Trial Results
Johnson & Johnson leveraged results from the regulatory Phase IIb SunRISe-1 study for the NDA submission. The study showed an 83.5 percent complete response (CR) rate in patients treated with TAR-200, with highly durable CRs without the need for reinduction. At a median follow-up of nine months, 82 percent of responders maintained their response. Additionally, TAR-200 demonstrated a good overall safety and tolerability profile, with a low occurrence of Grade 3 or higher treatment-related adverse events (TRAEs) (9 percent) and no treatment-related deaths.
Strategic Implications
The submission of the NDA for TAR-200 represents a significant step forward in Johnson & Johnson’s efforts to expand its oncology portfolio and address the needs of patients with HR-NMIBC. By leveraging the RTOR program, the company aims to expedite the review process and bring this innovative treatment to market as quickly as possible. This development is expected to enhance Johnson & Johnson’s position in the bladder cancer treatment landscape and contribute to the broader goal of improving patient outcomes.-Fineline Info & Tech
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