ImmunityBio is working to address the shortage and ongoing patient need of Bacillus Calmette-Guérin (BCG) by developing a new form of BCG called recombinant mycobacterium BCG (or rBCG) and making it available in the United States both through clinical trials and an Expanded Access program for patients that do not qualify for clinical trials.
What is BCG?
BCG is an immunotherapy drug used to treat early-stage bladder cancer, and other indications. For patients with bladder cancer, BCG is placed in the bladder through a catheter and triggers the body’s immune system to stop or slow the growth of cancer cells. BCG is approved by the U.S. Food and Drug Administration (FDA), and other regulatory agencies around the globe, to treat bladder cancer patients. Recombinant Bacillus Calmette-Guérin (rBCG) is an innovative version of traditional BCG-designed to potentially offer improved safety and immune activation.
What is Expanded Access?
Expanded access is a pathway that allows eligible patients to access investigational medicines outside of a clinical trial, when no comparable alternatives are available.
What is rBCG?
Since 2012, there has been a shortage of BCG as global demand outstrips the ability of the manufacturer to produce the product. In the United States, the shortage of BCG is estimated to be 40 thousand doses per year. ImmunityBio is working to address the shortage and ongoing patient need by developing a new form of BCG called recombinant mycobacterium BCG (or rBCG). We are testing rBCG in FDA approved clinical trials to determine whether it is as safe and effective as BCG.
ImmunityBio believes participating in clinical trials is the best way for patients to access medicines prior to approval. In pursuit of ImmunityBio’s objective to develop highly effective and safe therapeutic approaches, the successful completion of a clinical trial program of investigational products is the most effective way of ensuring timely review and decision-making by government regulatory agencies.
ImmunityBio believes participating in clinical trials is the best way for patients to access medicines prior to approval. In pursuit of ImmunityBio’s objective to develop highly effective and safe therapeutic approaches, the successful completion of a clinical trial program of investigational products is the most effective way of ensuring timely review and decision-making by government regulatory agencies.
Expanded Access Protocol
ImmunityBio will determine whether:
- There is sufficient clinical evidence to suggest acceptable safety and potential benefit
- Providing rBCG through expanded access will not interfere with clinical trial enrollment or regulatory milestones
- The patient is facing serious or life-threatening bladder cancer condition with no suitable approved therapies available
- A reliable supply rBCG is on hand
- It is logistically viable to distribute and administer rBCG outside of trial setting
ImmunityBio will assess the following:
- The patient’s individual medical circumstances do not create undue safety risks
- The treating physician is licensed, experienced, and has the necessary facilities to administer rBCG and to monitor, manage, and report side effects.
Requests for further information about how to apply for Expanded Access or determine qualifications and capabilities required to administer ImmunityBio investigational product can be made to bcg@immunitybio.com.
We typically will acknowledge receipt of a request for Expanded Access, with required medical documentation, within three business days. Our medical professionals will carefully consider requests considering access to open and accruing clinical trials, the serious/life-threatening nature of the disease, biological rationale or clinical data supporting potential benefit, medical appropriateness, and applicable laws and regulatory requirements. All physicians who receive ImmunityBio investigational product through Expanded Access are required to comply with all applicable laws and regulations, and contractual conditions, including those related to safety reporting.