- Authorized expanded access for ANKTIVA to treat lymphopenia, a life-threatening immune deficiency induced by chemotherapy, radiotherapy, and immunotherapy with depletion of natural killer (NK) and CD4+ CD8+ T cells (lymphocytes)
- Expanded Access includes all patients with solid tumors who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC
ImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors
On 6ix: 6ix.com/news/immunitybio-receives-fda-expanded-access-authorization-landmark-treatment-lymphopenia
Story so far
- Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up
- ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia
- ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch
Earlier from ImmunityBio
- ImmunityBio, Saudi Arabia’s Ministry of Investment, KFSHRC, and KAIMRC Sign Strategic Memorandum of Understanding to Launch Cancer BioShield™ Platform in the Middle East
- ImmunityBio Reports Doubled Net Revenue and 150% Unit Growth in Q1 2025, With Continued Strong Sales Momentum in First Quarter since J-code
- ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency’s Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025
- Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up
- ImmunityBio to Showcase Advances for Bladder and Prostate Cancer at American Urological Association (AUA) Annual Meeting
Later from ImmunityBio
- ASCO Report of Pioneering Treatment of Lymphopenia with Significant Overall Survival Benefit in Advanced Pancreatic Cancer
- UK MHRA Approves ImmunityBio’s ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
- ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors
- ImmunityBio Reports 60% Increase in Revenue in Q2 2025, with Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-Code with Regulatory Updates
- ImmunityBio Reports Q2 Earnings Release Reflecting 60% Increase in Revenue in Q2 2025, With Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-code
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