J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Breakthrough Treatments Transform Landscape for Rare Hemolytic Anemias: From C5 Inhibitors to Novel Therapeutic Approaches
• Recent advances in complement cascade inhibition therapy, led by anti-C5 drugs eculizumab and ravulizumab, have revolutionized treatment options for PNH and aHUS patients.
• Novel upstream complement inhibitors including pegcetacoplan (C3 inhibitor) and iptacopan (factor B inhibitor) demonstrate promising efficacy with significant hemoglobin improvements in clinical trials.
• Emerging treatments for warm autoimmune hemolytic anemia show promise, with fostamatinib and sovleplenib achieving notable response rates in recent clinical studies.
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