New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
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Johnson & Johnson has submitted a New Drug Application to the U.S. FDA for TAR-200, a novel treatment for BCG-unresponsive high-risk non-muscle-invasive bladder cancer. The application is under the FDA's Real-Time Oncology Review, supported by promising Phase 2b study results.
January 15, 2025 | 1:15 pm
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Johnson & Johnson has submitted a New Drug Application for TAR-200 to the FDA, targeting BCG-unresponsive bladder cancer. The application is under Real-Time Oncology Review, backed by strong Phase 2b results.
The submission of TAR-200 for FDA review, especially under the Real-Time Oncology Review program, indicates a potential for expedited approval. The high complete response rate in the Phase 2b study suggests strong efficacy, which could enhance JNJ's oncology portfolio and drive positive investor sentiment.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100