FDA提前近3个月批准ImmunityBio的ANKTIVA扩展至乳头状only型NMIBC，覆盖全部BCG无应答NMIBC患者

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 14, 2026
ImmunityBio, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-37507
43-1979754
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
3530 John Hopkins Court
San Diego
,
California
92121
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code:
(844)
696-5235
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.0001 per share
IBRX
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2
of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section13(a) of the Exchange Act. ☐
Item 7.01
Regulation FD Disclosure.
On October 14, 2026, ImmunityBio, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA
®
(nogapendekin alfa inbakicept-pmln) in combination with Bacillus
Calmette-Guérin
(BCG) to include patients with
BCG-unresponsive
NMIBC with papillary-only tumors. The full text of the Company’s press release is furnished as Exhibit 99.1 hereto.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
.
Exhibit
Number
Description of Exhibit
99.1*
Press Release dated October 14, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
*
Furnished herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
IMMUNITYBIO, INC.
Registrant
Date: October 14, 2026
By:
/s/ David C. Sachs
David C. Sachs
Chief Financial Officer

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EX-99.1
2
d188887dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
NEWS RELEASE
FDA Expands ANKTIVA
®
Approval
for
BCG-Unresponsive
Non-Muscle-
Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
•
Expanded indication extends ANKTIVA plus BCG to patients with
BCG-unresponsive
non-muscle-invasive
bladder cancer (NMIBC), including those with carcinoma in situ (CIS), with or without papillary tumors, and those with
papillary-only tumors
•
Papillary disease represents approximately 85% of the NMIBC patient population
1
•
This is the first FDA approval to include
BCG-unresponsive
NMIBC with
papillary-only tumors
•
With this FDA approval, access to ANKTIVA plus BCG expands to include all patients with
BCG-unresponsive
NMIBC
CULVER CITY, Calif., October 14, 2026 —
ImmunityBio,
Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA
®
(nogapendekin
alfa inbakicept-pmln) in combination with Bacillus
Calmette-Guérin
(BCG) to include patients with
BCG-unresponsive
NMIBC with papillary-only tumors.
The
expanded FDA label
reads as follows: Anktiva, in combination with Bacillus
Calmette-Guérin
(BCG), is
indicated for the treatment of adult patients with
BCG-unresponsive
non-muscle
invasive bladder cancer.
2
The broadened indication builds on
the FDA’s April 2024 approval of ANKTIVA plus BCG for patients with
BCG-unresponsive
NMIBC with carcinoma in situ (CIS)
.
3
with or without papillary tumors. CIS and papillary tumors are aggressive and associated with high
risk of recurrence and progression in the
BCG-unresponsive
setting. This is the first FDA approval to include
BCG-unresponsive
NMIBC with papillary-only tumors.
“This approval marks an important expansion of ANKTIVA plus BCG for patients with
BCG-unresponsive
NMIBC and
advances our goal of harnessing the patient’s own immune system to achieve durable, tumor-free outcomes,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.
“An important first step as we develop immunotherapy 2.0.”
The expanded approval is based on the FDA’s review of available scientific
information, including the previously demonstrated efficacy of ANKTIVA plus BCG in patients with
BCG-unresponsive
NMIBC with CIS, with or without papillary tumors. In Cohort A of the
QUILT-3.032
trial, 62% of 77 patients achieved a complete response (95% CI: 51, 73); among responders, 58% maintained a response for at least 12 months and 40% for at least 24 months.
4
The combination of ANKTIVA plus BCG has a tolerable safety profile, with the most common
treatment-related adverse events (TRAEs) related to bladder instillation (e.g., dysuria, pollakiuria, and hematuria), and most of these TRAEs were grade 1 to 2. This is consistent with the side effects of BCG alone.
4
The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
2
Expanding Treatment Options for
BCG-Unresponsive
NMIBC
Bladder cancer has among the most expensive cancers to treat over a patient’s lifetime
, reflecting the substantial costs associated with ongoing
surveillance, treatment, and disease management.
5
NMIBC accounts for
approximately 80% of all bladder cancer diagnoses
in the U.S. and includes both CIS and papillary tumors.
6
An estimated 85% to 90% of patients diagnosed with NMIBC present with papillary disease
.
7
Patients with high-grade papillary disease that
becomes unresponsive to BCG face an increased risk of recurrence and progression and often have limited nonsurgical treatment options.
“Patients
with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options,” said Sam S. Chang, M.D., Professor of Urology and Chief
Surgical Officer of the Vanderbilt Ingram Cancer Center. “The availability of an
FDA-approved
treatment for this population represents an important addition to the treatment landscape, providing
appropriate patients with
BCG-unresponsive
disease another treatment option that may help preserve the bladder.”
ANKTIVA’s expansion into
BCG-unresponsive
high-grade papillary-only NMIBC significantly increases its U.S.
addressable patient population beyond the currently approved CIS with or without papillary indication.
“The expansion of ANKTIVA plus BCG into
papillary-only disease broadens the eligible patient population and establishes it as the first
FDA-approved
therapy for both CIS and papillary-only disease in
BCG-unresponsive
NMIBC,” added Richard Adcock, President and CEO of ImmunityBio. “Building on strong commercial growth since ANKTIVA’s initial approval, we remain focused on helping eligible
patients access this therapy and are grateful to the patients, families, investigators, and clinical teams who made this progress possible.”
About ANKTIVA
®
(nogapendekin alfa inbakicept-pmln)
The
interleukin-15
(IL-15)
cytokine plays a crucial role in the immune system
by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and
restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a
first-in-class
IL-15
receptor agonist IgG1 fusion complex, consisting of an
IL-15
mutant
(IL-15N72D)
fused with an
IL-15
receptor alpha, which binds
with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound
IL-15
receptor alpha, delivering
IL-15
independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE:
ANKTIVA
®
is an
interleukin-15
(IL-15)
receptor agonist indicated in combination with Bacillus
Calmette-Guérin
(BCG) for the treatment of
adult patients with
BCG-unresponsive
nonmuscle invasive bladder cancer (NMIBC).
WARNINGS AND
PRECAUTIONS:
Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with
BCG-unresponsive
NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA
®
with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION:
For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
USE IN SPECIFIC POPULATIONS:
Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use
effective contraception.
ADVERSE REACTIONS:
The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased
creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA
®
at
Anktiva.com
.
About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the
patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological
memory in patients. At the core of our strategy is the Cancer BioShield
™
platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells,
cytotoxic T cells, and memory T cells via our proprietary
IL-15
receptor agonist, ANKTIVA
®
(nogapendekin alfa inbakicept). Our Cancer
BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic
(off-the-shelf)
and autologous
NK-cell
therapies, and additional immunomodulators intended to promote immunogenic cell death and
support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter),
Facebook
,
LinkedIn
, and
Instagram
.
References
1.
Anastasiadis A, de Reijke TM. Best practice in the treatment of nonmuscle invasive bladder cancer. Ther Adv
Urol. 2012
Feb;4(1):13-32.
doi: 10.1177/1756287211431976. PMID: 22295042; PMCID: PMC3263923. Available at
https://pmc.ncbi.nlm.nih.gov/articles/PMC3263923/
2.
https://anktiva.com/wp-content/uploads/ANKTIVA-Annotated-Approved-Label-Clean.pdf
U.S. Food and
Drug Administration (FDA). FDA approves nogapendekin alfa inbakicept-pmln for
BCG-unresponsive
nonmuscle invasive bladder cancer
. U.S. FDA April 2024.
3.
https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-
invasive-bladder-cancer/
4.
Chang SS, et al. J Urol. 2026;215(1):44–56. doi:10.1097/JU.0000000000004782.
5.
Mossanen M, Gore JL. The burden of bladder cancer care: direct and indirect costs.
Curr Opin
Urol.
2014;24(5):487–491. doi:10.1097/MOU.0000000000000078.
6.
PubMed Central.
https://pmc.ncbi.nlm.nih.gov/articles/PMC3263923/.
7.
Song J, et al. Contemporary data on incidence, treatments and outcomes of high-grade NMIBC in the US. Presented
at: New England AUA Annual Meeting; 2019.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements
contained in this press release other than statements of historical fact, including statements regarding the potential benefits, commercial opportunities, market potential, and anticipated impact of the U. S. Food and Drug Administration’s
approval of the expanded indication for ANKTIVA
®
(nogapendekin alfa inbakicept-pmln) are forward-looking statements.
Forward-looking statements include, without limitation, statements regarding the Company’s expectations, beliefs, plans, objectives, strategies,
prospects, and future performance relating to: the potential clinical benefits, safety, effectiveness, utility, and therapeutic value of ANKTIVA
®
for patients within the newly approved
indication; the potential for ANKTIVA
®
to address unmet medical needs, improve patient outcomes, or become an important treatment option or standard of care; the size and characteristics of
the patient population eligible for treatment; the potential market opportunity and commercial potential associated with the expanded indication; the anticipated timing, scope, effectiveness, and success of the Company’s commercialization,
promotional, marketing, medical affairs, market access, and product launch activities; the anticipated adoption, utilization, prescribing patterns, and acceptance of ANKTIVA
®
by physicians,
patients, healthcare providers, payors, and other stakeholders; the Company’s ability to obtain, maintain, or expand adequate coverage, reimbursement, formulary access, and favorable pricing for ANKTIVA
®
; the anticipated effect of the expanded indication on product demand, sales, revenue, profitability, cash flows, financial condition, and future operating results; the Company’s ability to
manufacture, supply, distribute, and commercialize sufficient quantities of ANKTIVA
®
to meet anticipated demand; the potential competitive positioning of ANKTIVA
®
relative to existing and future treatment alternatives; and the Company’s plans and expectations concerning additional clinical development, regulatory submissions, label expansions,
lifecycle management, and other potential opportunities for ANKTIVA
®
.
These statements may be
identified by words such as “aim,” “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “forecast,” “goal,”
“intend,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,”
“will,” “would,” and similar expressions.
These forward-looking statements are based on the Company’s current expectations,
estimates, forecasts, assumptions, and beliefs as of the date of this press release and involve known and unknown risks, uncertainties, assumptions, and other factors, many of which are outside the Company’s control, that could cause
actual results, developments, performance, or achievements to differ materially from those expressed, implied, or anticipated by such statements. Such risks and uncertainties include, among others: the possibility that the expanded indication
for ANKTIVA
®
will not
result in the anticipated levels of physician adoption, patient utilization, market penetration, product demand, or commercial success; that the actual number of patients eligible for or
receiving treatment may be smaller than anticipated; that physicians, patients, treatment guidelines, healthcare institutions, or payors may not adopt or support use of ANKTIVA
®
to the extent
or within the time frames anticipated; that clinical experience following approval may differ from results observed in clinical trials; that additional safety, tolerability, efficacy, or other product-related information, including adverse events or
previously unidentified risks, may emerge through post-marketing surveillance, real-world use, or additional studies; and that the Company may encounter unexpected challenges in complying with ongoing regulatory requirements, including those
governing manufacturing, product quality, pharmacovigilance, advertising, promotion, and commercialization. Additional risks and uncertainties include: the Company’s ability to successfully execute its commercial strategy for the expanded
indication; the effectiveness of its sales force, marketing initiatives, medical education efforts, distribution arrangements, and other commercialization activities; limitations on the Company’s ability to promote ANKTIVA
®
outside its approved labeling; the availability, scope, timing, and adequacy of coverage and reimbursement from Medicare, Medicaid, commercial insurers, and other third-party payors; pricing
pressures, rebates, discounts, utilization management restrictions, prior authorization requirements, and changes in healthcare laws, regulations, and reimbursement policies; the impact of federal and state drug pricing initiatives and other
healthcare cost-containment measures; competition from currently marketed products, newly approved therapies, generic products, biosimilars, and other existing or emerging treatment modalities; changes in clinical practice guidelines or treatment
paradigms; the ability of the Company and its third-party manufacturers and suppliers to maintain adequate manufacturing capacity, product quality, inventory levels, and reliable supply chains; manufacturing deviations, quality-control issues,
product shortages, recalls, or disruptions in distribution; and the Company’s ability to protect, maintain, and enforce intellectual property rights, regulatory exclusivities, and other proprietary rights relating to ANKTIVA
®
.
More details about these and other risks that may impact ImmunityBio’s business are
described under the heading “Risk Factors” in the Company’s Annual Report on
Form 10-K
filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026,
Quarterly Report on Form
10-Q
filed with the SEC on August 4, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio
cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to
the extent required by law.
ImmunityBio Contacts:
Investors
Media
Hemanth Ramaprakash, PhD, MBA
Sarah Singleton
ImmunityBio, Inc.
ImmunityBio, Inc.
+1
858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
+1
415-290-8045
Sarah.Singleton@ImmunityBio.com