Full Press Release Details
Citius Oncology Anticipates Commercial Launch
CRANFORD, N.J., June 17, 2025 - Citius
Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius
Pharma") (Nasdaq: CTXR), today announced that preparations for the commercial launch of LYMPHIR , an FDA-approved immunotherapy
for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), are nearing completion. The Company believes
it is now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization, with
all major launch-enabling activities underway. Final preparations are in process for a U.S. launch of LYMPHIR in the second half of 2025.
"We've made steady and meaningful
progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius
Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged
by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned
2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community," added
Manufacturing and Supply Chain Readiness
Citius Oncology has completed commercial-scale
manufacturing of LYMPHIR, with packaged and labeled inventory now held at a leading global Contract Development and Manufacturing Organization
(CDMO). Sufficient inventory has been manufactured, with a product shelf life of 60 months, to meet projected demand for 12 to 18 months
Citius Oncology has executed one and is finalizing
other distribution services agreements with multiple top-tier global pharmaceutical logistics partners to support broad access and timely
delivery across the United States. These agreements are intended to provide access for CTCL patients so that they may be treated at both
major cancer centers and within the community setting.
As part of its extensive market research efforts,
our team has engaged U.S. Key Opinion Leaders (KOLs) in CTCL and participated in a series of medical congresses and community forums to
build awareness and gather insight. Our engagement with the Cutaneous Lymphoma Foundation and similar organizations continues to shape
LYMPHIR's patient-centered commercial approach.
A recent Advisory Board convened at the 2024 American
Society of Hematology Annual Meeting, composed of leading CTCL experts, provided us with information that informed both launch strategy
and refinement of target patient profiles.
Early interest from the clinical community is
evident, with 70 institutional oncology centers already signed up via the LYMPHIR website (www.lymphirhcp.com).
Commercial & Marketing Activities
The commercial team has developed a targeted launch
strategy that leverages a proprietary generative AI model to efficiently and effectively target key accounts. These efforts are designed
to amplify the expertise of the commercial organization so that they may have more meaningful interactions with providers, ultimately
reaching CTCL patients who would benefit from LYMPHIR more expeditiously.
A comprehensive suite of marketing and educational
materials has been developed to support LYMPHIR's introduction. These tools are tailored to providers, patients, and caregivers
and include clinical guides, dosing protocols, and disease awareness content.
Market Access Update
LYMPHIR's inclusion in the National Comprehensive
Cancer Network (NCCN) Clinical Practice Guidelines, assignment of a permanent J-code under HCPCS, and Citius Oncology's continued
engagement with payors, positions the product for efficient reimbursement and coverage at launch.
Financing and Strategic Partnerships
The successful capital raise recently completed
by Citius Pharma assists with final preparations for LYMPHIR's commercialization, supporting the planned launch of LYMPHIR in the
second half of 2025. Concurrently, the Company is actively engaged in strategic partnership discussions, guided by its financial advisor,
to expand LYMPHIR's market reach and evaluate potential future development opportunities.
About LYMPHIR (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed
or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It
is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically
binds to IL-2 receptors on the cell surface of tumor cells and immunosuppressive regulatory T-cells (T-regs) and is internalized. After
uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. This action
leads to direct tumoricidal effects as well as a transient depletion of T-regs to enhance overall antitumor activity.
In 2021, denileukin diftitox received regulatory
approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius
acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for Japan and certain
parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous
non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type
of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality
of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and S zary Syndrome (SS) comprise
the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to
upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can
spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle
through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients
between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients
qualify, there is currently no curative therapy for advanced CTCL.
LYMPHIR is an IL2-receptor-directed cytotoxin
indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening
or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold
LYMPHIR until CLS resolves, or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS),
including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following
symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur
simultaneously to be characterized as capillary leak syndrome.
As defined, CLS occurred in 27% of patients in
the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients
with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset
from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution.
The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also
Regularly assess patients for weight gain, new
onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation
of each cycle of therapy and more often as clinically indicated.
Withhold, reduce dose, or permanently discontinue
based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal
LYMPHIR can cause serious visual impairment, including
changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade
1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution
of their visual impairment.
Perform baseline ophthalmic examination and monitor
as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision,
or blurred vision, refer for ophthalmologic evaluation.
Withhold LYMPHIR until visual impairment resolves
or permanently discontinue based on severity.