ImmunityBio is working to address the shortage and ongoing patient need of Bacille 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.
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.
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. This will ultimately result in access to new, safe and effective approved therapies for patients. For these reasons, ImmunityBio prioritizes access to its investigational products through active and accruing clinical trials and encourages interested patients to enroll.
While this testing continues, ImmunityBio has committed to helping patients with early-stage bladder cancer by making rBCG available, when appropriate, through an Expanded Access program in the United States. An eligible physician may request access to rBCG by registering their practice/hospital via the following form.
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 taking into account 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.