ImmunityBio and Serum Institute Address BCG Shortage with FDA-Approved Expanded Access Program

FDA Authorizes Alternative BCG Source Amid Merck Supply Constraints

The U.S. Food and Drug Administration (FDA) has authorized ImmunityBio's expanded access program (EAP) to introduce an alternative source of Bacillus Calmette-Guérin (BCG) to the United States. This decision comes as a response to ongoing supply challenges faced by Merck & Co., the sole manufacturer of BCG in the country for over a decade.

BCG, originally developed as a tuberculosis vaccine, plays a crucial role in the treatment of non-muscle invasive bladder cancer (NMIBC), which accounts for approximately 80% of the estimated 80,000 new bladder cancer diagnoses annually in the U.S. The bacteria-based biologic has been a cornerstone of NMIBC treatment since 1921.

ImmunityBio's collaboration with the Serum Institute of India (SII) will bring recombinant BCG to the U.S. market. This new formulation carries two gene modifications designed to enhance immunogenicity and safety compared to earlier strains. Dr. Patrick Soon-Shiong, ImmunityBio's founder and chief scientific and medical officer, emphasized the importance of this initiative, stating, "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."

Impact of BCG Shortage on Bladder Cancer Treatment

The shortage of Merck's TICE BCG has significantly impeded bladder cancer treatment in the United States. A recent Sermo survey revealed that 57% of 100 U.S. urologists were unable to treat patients in the past 12 months due to limited access to TICE BCG.

Merck has been aware of the supply issues and announced plans in late 2020 to construct a new TICE BCG plant in North Carolina. The facility, expected to triple production capacity, is slated for completion between late 2025 and late 2026. However, this timeline leaves a considerable gap in meeting current demand.

ImmunityBio's expanded access program aims to address this critical shortage immediately. The company has confirmed that supplies of the therapeutic are now available, with shipments set to begin promptly through the FDA's access program.

Anktiva Approval and BCG Supply Strategy

In April 2024, ImmunityBio received its first U.S. approval for Anktiva, an IL-15 bladder cancer drug, to be used in combination with BCG for certain NMIBC patients. Recognizing the potential strain on BCG supplies following Anktiva's approval, ImmunityBio proactively partnered with the Serum Institute of India in May 2024 to ensure large-scale production of BCG for use with their new drug.

This strategic partnership has now evolved into the FDA-approved expanded access program, positioning ImmunityBio and SII as key players in addressing the BCG shortage. The collaboration not only supports the rollout of Anktiva but also provides a much-needed alternative source of BCG for the broader bladder cancer patient population in the United States.