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Nmibc

All articles tagged with #nmibc

health16 days ago•12 min saved

FDA Reviews Expanded ANKTIVA+BCG Indication for Papillary NMIBC; PDUFA Set for January 2027

ImmunityBio disclosed that the FDA has accepted for review a supplemental Biologics License Application to expand ANKTIVA when combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with papillary disease (no CIS). The FDA assigned a PDUFA target date of January 6, 2027. The submission relies on QUILT-3.032 Cohort B data and literature suggesting papillary NMIBC shares a biological profile with CIS, potentially allowing extrapolation from CIS trials. If approved, the expansion would broaden ANKTIVA+BCG to papillary-only NMIBC, offering a bladder-sparing, immunotherapy option and potentially delaying cystectomy, with safety data consistent with BCG alone and support from NCCN Category 2A guidance.

via ImmunityBio|

#anktiva #bcg #fda

business17 days ago•9 min saved

ImmunityBio's NAI+BCG Delivers More Durable Complete Responses in BCG-Unresponsive NMIBC at AUA 2026

ImmunityBio presented indirect treatment comparison analyses at AUA 2026 showing nogapendekin alfa inbakicept-pmln (NAI) plus BCG achieving higher and longer-lasting complete responses than nadofaragene firadenovec-vncg in BCG-unresponsive NMIBC with CIS (anytime CR 69.7% vs 53.4%; median CR duration 22.1 vs 9.7 months; cystectomy-free HR 0.40). In comparison with TAR-200, NAI+BCG had a higher 12‑month CR (49.2% vs 45.9%) and substantially fewer treatment-related adverse events (61.7% vs 83.5%) based on MAIC analyses. Results are from unanchored indirect comparisons and should be interpreted with caution, but support IL-15–driven, bladder-sparing immunotherapy potential in NMIBC with CIS. The company also cites ongoing BCG development efforts, including Tokyo strain and recombinant BCG programs.

via ImmunityBio|

#anktiva #aua-2026 #bladder-cancer

business3 months ago•19 min saved

ImmunityBio’s ANKTIVA Delivers 700% Revenue Jump, Expands to 33 Countries and Secures First Lung Cancer Approval

ImmunityBio reports 2025 ANKTIVA net product revenue of about $113 million (up ~700% YoY) with 750% unit growth, expanding approvals to 33 countries across four jurisdictions and securing Saudi Arabia’s first lung-cancer approval, while strengthening European and Middle East partnerships and outlining a 3-year plan to use ANKTIVA as the Cancer BioShield backbone across multiple trials.

via ImmunityBio|

#anktiva #business #immunitybio

biotechnology4 months ago•11 min saved

ImmunityBio Pursues FDA Path to Resubmission for ANKTIVA in Papillary NMIBC

ImmunityBio announced a productive Type B End‑of‑Phase meeting with the FDA regarding its supplemental Biologics License Application for ANKTIVA plus BCG in BCG‑unresponsive papillary NMIBC. The FDA asked for additional information (not new trials) to support a potential resubmission, which ImmunityBio will provide within 30 days. Long‑term QUILT‑3.032 data in 80 patients show about 96% bladder cancer‑specific survival at 36 months and high cystectomy‑free survival (roughly 82–93% at 12–36 months), underscoring a bladder‐sparing, chemo‑free approach. ANKTIVA is already approved for CIS in the US, UK, and Saudi Arabia, with EU conditional status for CIS and ongoing EMA discussions to extend labeling to papillary disease if US approval is achieved.

via Business Wire|

#antkiva #biotechnology #bladder-cancer