ImmunityBio to Supply Recombinant BCG to Alleviate Tice BCG Shortage
FDA approves an expanded access program that would offer patients an alternative to Merck’s bladder cancer medication.
The FDA has approved an expanded access program that will provide an alternative for Tice BCG—a Merck medication that treats various types of bladder cancer—to patients in the United States.1
A rise in global demand has resulted in supply shortages of Tice BCG in the country, which have impacted the treatment of bladder cancer patients. In fact, a recent Sermo survey of 100 US urologists noted that 57% of them were unable to treat patients in the last year, specifically due to a lack of access.
The Serum Institute of India has created the alternative BCG source. Clinical trials in Europe have shown that the recombinant BCG vaccine provides “potent immunogenicity” with CD8+ and CD4+ T cell stimulation, while safety has improved compared to previous BCG strains and formulations.
“With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics,” commented Dr. Patrick Soon-Shiong, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio. “Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients.”
BCG was originally created as a live vaccine to fight tuberculosis (TB), based on the Mycobacterium bovis (M. bovis) Bacillus Calmette-Guérin (BCG) strain. It is administered through intravesical instillation (delivery to the bladder via a catheter) and has been the go-to of care for non-muscle invasive bladder cancer (NMIBC) since the late 70s. It works by inducing an immune response in the bladder in proximity to the cancer cells.
In other ImmunityBio news, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has officially validated and accepted the marketing authorization application for Anktiva (nogapendekin alfa inbakicept-pmln), an IL-15 agonist IgG1 fusion complex.2 The MHRA will start to review the marketing authorization application for Anktivain combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
“MHRA’s acceptance of our marketing authorization application for the UK comes less than three weeks after the European Medicines Agency accepted for review our MAA for the 30 countries covering the European Union, and just 10 months after FDA approval in the United States,” added Soon-Shiong. “We are determined to reach as many patients as possible with Anktiva and BCG and are encouraged by the momentum of our efforts.”
References
1. FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address Tice BCG Shortage. ImmunityBio, Inc. February 19, 2025. Accessed February 20, 2025. https://immunitybio.com/fda-authorizes-immunitybio-to-provide-recombinant-bcg-rbcg-to-urologists-to-address-tice-bcg-shortage/
2. ImmunityBio Announces UK Medicines and Healthcare Products Regulatory Agency Accepted Marketing Authorization Application for Anktiva for the Treatment of Patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ. ImmunityBio, Inc. February 13, 2025. Accessed February 20, 2025. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-uk-medicines-and-healthcare-products?field_nir_news_date_value[min]=
