RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) has begun the process for U.S. Food and Drug Administration (FDA) approval of TAR-200, a new treatment option for high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients. The submission, under the FDA's Real-Time Oncology Review (RTOR) program, is based on the Phase 2b SunRISe-1 study results, which reported an 83.5 percent complete response rate among participants.
TAR-200, an investigational intravesical drug releasing system, is designed to deliver gemcitabine locally to the bladder, offering a potentially less invasive treatment than the current standard, radical cystectomy. The treatment, which can be administered by a healthcare professional in an outpatient setting without anesthesia, has been granted Breakthrough Therapy Designation by the FDA as of December 2023.
The SunRISe-1 study, which supported the application, showed not only a high complete response rate but also a durable response over a median follow-up of nine months. Safety and tolerability data indicated a low occurrence of Grade 3 or higher treatment-related adverse events. With the company maintaining strong financial health and a robust R&D pipeline, InvestingPro data reveals 8 additional key insights about Johnson & Johnson's market position and future prospects, available in the comprehensive Pro Research Report.
HR-NMIBC, characterized by a higher likelihood of recurrence and progression to invasive bladder cancer, presents a significant challenge, especially for older patients who may be unable or unwilling to undergo radical cystectomy. Johnson & Johnson's application for TAR-200 aims to address this unmet medical need.
The company's Global Therapeutic Head of Oncology, Dr. Yusri Elsayed, emphasized the potential impact of TAR-200, stating that it promises to be a meaningful addition to treatment options for NMIBC patients.
This news is based on a press release statement and reflects the ongoing commitment of Johnson & Johnson to innovate in the field of oncology and provide new solutions for complex diseases. The FDA's decision on the application for TAR-200 is awaited with interest by the medical community and patients alike.
In other recent news, Johnson & Johnson's 'AAA' credit rating is under review by S&P Global Ratings following its acquisition of Intra-Cellular Therapies (NASDAQ:ITCI) Inc. The acquisition is expected to raise the company's leverage, triggering a potential downgrade. Despite this, projections suggest that Johnson & Johnson will lower its leverage within the next two years. The acquisition of Intra-Cellular aligns with Johnson & Johnson's strategy of completing moderate-size acquisitions to strengthen its portfolio and pipeline.
Morgan Stanley (NYSE:MS) reaffirmed its Equalweight rating for Johnson & Johnson following the recent deal, noting the strategic fit for the company's portfolio. The acquisition of Caplyta is anticipated to bolster Johnson & Johnson's offerings in the CNS/neuro segment.
Johnson & Johnson has also received Fast Track designation from the FDA for two investigational Alzheimer's disease therapies, posdinemab and JNJ-2056. This designation is expected to expedite the review of these drugs, potentially leading to earlier patient access. However, it's important to note that these treatments are still under investigation, and there is no guarantee of clinical success or regulatory approval.
Finally, concerns have been raised regarding Johnson & Johnson's cardiac ablation device, Varipulse, contributing to a temporary pause in its use. The company is investigating the cause behind four neurovascular events related to the device.
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