A provider-focused guide to Anktiva and BCG supply challenges in 2026. Covers ordering, reimbursement, BCG allocation strategies, and alternative protocols.
Since its FDA approval in April 2024, Anktiva (nogapendekin alfa inbakicept-pmln) has rapidly become an important treatment option for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. ImmunityBio reported 700% year-over-year revenue growth for the drug in 2025, reflecting growing adoption across urology practices and cancer centers.
However, significant supply and access challenges remain — most critically, the ongoing BCG shortage that directly impacts Anktiva's utility. This guide provides urologists, oncologists, and practice administrators with the information needed to navigate these challenges in 2026.
Anktiva supply from ImmunityBio has been scaling to meet demand. The drug is not currently listed on the FDA drug shortage database. It is distributed through specialty channels, primarily Cencora (formerly AmerisourceBergen), using the buy-and-bill model.
Key ordering details:
The primary barrier to Anktiva utilization remains the BCG (TICE BCG) shortage. Merck continues as the sole U.S. manufacturer, and supply has been inadequate for several years. Key developments:
For practices managing limited BCG supply, prioritization of BCG for Anktiva combination therapy in eligible patients represents a clinical and logistical decision that should be made at the institutional level.
Coverage for Anktiva has expanded significantly since the permanent J-code was issued in January 2025. Key payer considerations:
ImmunityBio offers the CARE program to support provider offices with reimbursement navigation:
For detailed reimbursement guidance, providers can access the official ordering and reimbursement resources on the Anktiva HCP website.
The approved dosing regimen for Anktiva with BCG:
From the pivotal QUILT-3.032 trial:
Most adverse reactions are local and consistent with intravesical therapy:
Important safety communications: The label includes a warning regarding delayed cystectomy — providers should discuss with patients that the risk of metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
Given the ongoing BCG shortage, providers should consider developing institutional protocols for BCG allocation. Considerations include:
If your practice does not currently carry Anktiva or lacks BCG supply, consider referring eligible patients to:
You can direct patients to MedFinder for Providers as a tool for locating treatment centers with current Anktiva availability.
ImmunityBio has submitted a supplemental BLA for Anktiva + BCG in papillary-only BCG-unresponsive NMIBC, supported by long-term disease-free survival data from the QUILT-3.032 trial. Additionally, the company is investigating Anktiva in combination with chemotherapy and checkpoint inhibitors for non-small cell lung cancer (NSCLC).
The European Medicines Agency recommended conditional marketing authorization for Anktiva with BCG in NMIBC CIS, with six BCG strains available in Europe for combination use.
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