ImmunityBio (NASDAQ:IBRX) saw its shares climb 17.1% on Wednesday following a decision by the European Commission to grant conditional marketing authorization for the company’s bladder cancer immunotherapy, ANKTIVA, when used alongside bacillus Calmette-Guerin (BCG).
The approval allows ANKTIVA in combination with BCG to be marketed across all 27 European Union member states and in Iceland, Norway and Liechtenstein. That regulatory green light expands ANKTIVA’s availability to a total of 33 countries and marks the therapy’s first authorization on the European continent for this particular indication.
ANKTIVA is authorized for use in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) that presents with carcinoma in situ (CIS). Until now, patients with this form of disease in Europe had no authorized non-surgical therapy and often faced radical cystectomy as the primary alternative. The company described the authorization as a milestone for affected patients.
Clinical trial results cited by the company show a 71% complete response rate for ANKTIVA, with a median duration of response of 26.6 months. The company has reported individual responses extending beyond 54 months in some patients. ANKTIVA now holds authorizations in four regulatory jurisdictions, including prior approvals in the United States, United Kingdom and Saudi Arabia.
"The European Commission’s authorization of ANKTIVA in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative," said Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio.
Bladder cancer imposes a notable clinical burden in Europe. More than 150,000 patients are diagnosed annually with NMIBC, and roughly 75% of bladder cancer cases are of the non-muscle invasive subtype, confined to the bladder lining and not yet having invaded the muscle layer.
With regulatory clearance now in hand, the company said its near-term focus will be on achieving pricing and reimbursement approvals across individual European markets to facilitate patient access. The company noted that, unlike the situation in the United States, Europe has approvals for roughly six major BCG strains, which supports a reliable supply for the combination regimen.
Market reaction to the authorization was immediate, reflected in the stock’s intraday move, while ImmunityBio’s next operational steps center on payer negotiations and market access work across the newly authorized countries.