FDA broadens ImmunityBio’s ANKTIVA bladder cancer approval
On October 14, the FDA expanded ImmunityBio’s ANKTIVA-plus-BCG indication to high-risk BCG-unresponsive non-muscle-invasive bladder cancer with papillary-only tumors. Prior evidence cited for the label expansion included a 62% complete-response rate, while 58% of responders remained in response for at least 12 months. The broader authorization proceeded without a separate Phase III trial and extends the earlier CIS-based indication.
Why it matters
The label change makes papillary-only patients eligible for ANKTIVA and enlarges the drug’s potential treatment population; describes this group as upwards of 60% of high-risk BCG-unresponsive NMIBC patients. H.C. Wainwright reiterated a Buy rating and a $15.00 price target after the decision,.
Key facts
- 1The FDA added high-risk BCG-unresponsive NMIBC with papillary-only disease to ANKTIVA’s indication. investing.com
- 2The efficacy evidence cited for the expansion included a 62% complete-response rate. investing.com
- 3Among responders, 58% maintained a complete response for at least 12 months. investing.com
- 4Papillary-only disease represents upwards of 60% of high-risk BCG-unresponsive NMIBC patients. investing.com
- 5The US label expansion did not require a separate Phase III trial. finance.yahoo.com
- 6H.C. Wainwright reiterated a Buy rating and a $15.00 price target for ImmunityBio. investing.com
Summary written by AlphAI AI Desk from 7 of 8 sources. Not investment advice. Figures are as stated by the linked sources.