FDA approved the drug Anktiva for adults with high-grade papillary-only non-muscle invasive bladder cancer that has not responded to a specific therapy called Bacillus Calmette-Guérin and has not invaded the bladder muscle.
- The FDA relied on evidence from Anktiva’s earlier approval in carcinoma in situ (CIS)—with or without papillary tumors—together with clinical and laboratory data showing key similarities between CIS and high-grade papillary tumors for the approval.
- The FDA was expected to decide on the company’s application by January 6.
- ImmunityBio Chairman Pat Soon-Shiong said in a post on X that the company will discuss its status in treating non-muscle invasive bladder cancer on Friday.
The U.S. Food and Drug Administration said on Wednesday that it has approved ImmunityBio Inc.’s (IBRX) drug Anktiva for adults with high-grade papillary-only non-muscle invasive bladder cancer (NMIBC) that has not responded to a specific therapy called Bacillus Calmette-Guérin (BCG) and has not invaded the bladder muscle.
The approval, which came months ahead of the agency’s January deadline, expands the drug’s treatable population, as it is already approved for other indications. It will be administered with BCG directly into the bladder through a catheter.
IBRX stock opened 1.5% lower but pared losses and was up 5% at the time of writing.
How The FDA Justified The Broader Label
The FDA relied on evidence from Anktiva’s earlier approval in carcinoma in situ (CIS)—with or without papillary tumors—together with clinical and laboratory data showing key similarities between CIS and high-grade papillary tumors for the approval. The drug was first approved in 2024 for BCG-unresponsive Carcinoma in Situ. In the QUILT-3.032 trial, 62% of 77 adults achieved a complete response, meaning no high-grade cancer was detected during follow-up assessments, with 58% of responders maintaining it for at least 12 months and 40% for at least 24 months. The expanded approval draws on the same trial results.
“For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments,” said R. Angelo de Claro, Director of the FDA’s Oncology Center of Excellence.
ImmunityBio Chairman Pat Soon-Shiong said in a post on X that the company will discuss its status in treating non-muscle invasive bladder cancer on Friday. Soon-Shiong is slated to speak at a fireside chat at the Piper Sandler Virtual Oncology Symposium on Friday on the company’s clinical progress and vision for cancer immunotherapy.
Anktiva has also gained authorization in the UK, EU, Saudi Arabia, and additional markets for the CIS-containing NMIBC population. Saudi Arabia has also granted conditional approval for use with checkpoint inhibitors in metastatic non-small cell lung cancer.
ImmunityBio is pursuing further expansion, including a planned supplemental application for BCG-naïve NMIBC and ongoing work in lung cancer, glioblastoma, lymphoma, and lymphopenia management.
How Did IBRX Retail Traders React?
On Stocktwits, retail sentiment around IBRX stock stayed within ‘neutral’ territory over the past 24 hours, while message volume fell from ‘normal’ to ‘low’ levels.
A Stocktwits user voiced optimism for a rally on Friday with the company’s update.
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Another voiced hopes for the new approval doubling income for the company.
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IBRX stock has rallied over 400% year-to-date.
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