BCG vaccine
- Generic Name
- BCG vaccine
- Drug Type
- Biotech
- Unique Ingredient Identifier
- 8VJE55B0VG
- Background
BCG vaccine has been investigated for the treatment of Neoplasms, Bladder Cancer, Neoplasms by Site, Urologic Diseases, and Urologic Neoplasms, among others.
- Associated Conditions
- Non-Invasive Bladder Urothelial Carcinoma, Recurrent Superficial Bladder Cancer, Tuberculosis (TB), Urothelial Carcinoma Recurrent, Carcinoma in situ of urinary bladder
FDA Approves Miudella: First New Copper IUD in Four Decades Expands Contraceptive Options
• The FDA has granted approval to Miudella, marking the first new hormone-free copper IUD introduction in the United States market since 1984, offering three years of effective contraception.
• Miudella joins Paragard as only the second non-hormonal IUD option available in the U.S., expanding choices for women seeking long-term reversible contraception without hormones.
• With IUDs being approximately 99% effective at preventing pregnancy and currently used by 10% of reproductive-age women in the U.S., this approval addresses growing demand for hormone-free contraceptive options.
ImmunityBio's Anktiva Pursues European and UK Approval for BCG-Unresponsive Bladder Cancer
• ImmunityBio's Anktiva, combined with BCG, seeks approval in the EU and UK for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
• The MAAs submitted to the EMA and MHRA are supported by Phase 2/3 QUILT-3.032 trial data, demonstrating a 71% complete response rate in patients with NMIBC with CIS.
• Regulatory assessments by both agencies are anticipated to conclude by Q4 2025, potentially leading to approval in Europe and the UK by 2026, expanding global access.
• ImmunityBio also plans to submit a supplemental BLA to the FDA in 2025, seeking approval for Anktiva in patients with BCG-unresponsive NMIBC in the papillary indication.
Durvalumab Gains Priority Review for Muscle-Invasive Bladder Cancer Treatment
• The FDA has granted priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC), potentially expediting its approval.
• Phase 3 NIAGARA trial data supports the application, showing a 32% reduction in disease progression or recurrence with perioperative durvalumab.
• The Imfinzi regimen also demonstrated a 25% reduction in the risk of death, offering a significant survival benefit.
• Regulatory decisions are anticipated in the second quarter of 2025, with potential implications for MIBC treatment standards.
EU Mulls Paying for Late-Stage Neglected Disease Drug Research
• The EU's Health Emergency Preparedness and Response Authority (HERA) is considering pull incentives to bolster neglected disease drug development.
• HERA may fund late-stage research needed for marketing authorization, aiming to align developer interests with public health needs.
• Advance market commitments and demand estimations are also under consideration to improve market viability for these products.
• A €20m loan was granted to Fabentech to develop a technology platform against deadly viruses and toxins under the HERA Invest initiative.
Drug Development Updates
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