ImmunityBio, Inc. shared on LinkedIn:
“We are pleased to announce that the U.S. Food and Drug Administration (FDA) has expanded the indication for ANKTIVA (nogapendekin alfa inbakicept‑pmln) + BCG to include patients with BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) with papillary‑only tumors.
This milestone makes ANKTIVA + BCG the first FDA‑approved therapy for both CIS and papillary‑only disease in the BCG‑unresponsive NMIBC setting. Because papillary tumors represent approximately 85 % of NMIBC diagnoses, this approval significantly broadens access to a bladder‑sparing option for patients who face high risk of recurrence and progression.”
Key details of the FDA approval are summarized below:
- The approval expands the previous indication, which was limited to patients with carcinoma in situ (CIS), with or without papillary tumors, to include patients with high-grade papillary-only tumors.
- The complete response rate was 62% (95% CI: 51-73). Among patients who achieved CR, 58% maintained their response for at least 12 months. Among patients who achieved CR, 40% maintained their response for at least 24 months.
- The FDA expanded the indication to include patients with BCG-unresponsive high-grade papillary-only NMIBC following a review of available scientific information.
- Based on their overlapping clinical and nonclinical characteristics, the FDA concluded that the previously demonstrated efficacy of nogapendekin alfa inbakicept-pmln with BCG in CIS-containing NMIBC could be extrapolated to patients with high-grade papillary disease.
- The most common adverse reactions and laboratory abnormalities, reported in at least 15% of patients, included increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.
- The prescribing information also includes an important warning that delaying cystectomy may lead to the development of metastatic bladder cancer, which can be lethal.
Read the full FDA approval article.
Learn more: FDA Approves Expanded Indication for Anktiva in BCG-Unresponsive NMIBC
