On January 7, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include three additional combination arms (Press release, Immuneering, JAN 7, 2025, View Source [SID1234649467]). While approved MEK inhibitors mainly benefit a subset of patients with BRAF-driven tumors, IMM-1-104 was designed to improve tolerability and expand indications to include RAS-mutated tumors such as those found in most pancreatic cancers.

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"We are excited to report an updated ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. For reference, the benchmark reported for gemcitabine/nab-paclitaxel in this setting had an ORR of 23% and DCR of 48%. We look forward to reporting further data in the second quarter of 2025 and have started planning for a potential pivotal clinical trial," said Ben Zeskind, Ph.D., CEO of Immuneering.

Dr. Zeskind continued: "Today we are also sharing initial data from IMM-1-104 in combination with modified FOLFIRINOX in first-line pancreatic cancer patients. We observed target lesion shrinkage across all evaluable patients, including a 100% reduction, a rare event in this patient population. Additionally, we are reporting initial data from our monotherapy arm of IMM-1-104 in second-line pancreatic cancer. We saw clear activity, including a partial response with a 67% target lesion reduction. We believe these results provide substantiating evidence of IMM-1-104’s contribution in combination with current therapies."

Dr. Zeskind concluded: "Importantly, we continue to observe a highly differentiated safety profile for IMM-1-104, which we designed to be better tolerated and more active than existing approved MEK inhibitors already driving annual net sales of ~$2.4 billion in 2023. Accordingly, we plan to add three new Phase 2a combination arms: IMM-1-104 with a BRAF inhibitor in BRAF-mutant melanoma, and IMM-1-104 with an immune checkpoint inhibitor in both melanoma and NSCLC. We expect to initiate these arms in 2025. Today we are setting a path to break new ground in indications where no MEK inhibitors have been approved, including pancreatic cancer, and aim to provide a better tolerated and more effective alternative where MEK inhibitors are already helping patients."

Updated Data from Phase 2a Arm Evaluating IMM-1-104 with Modified Gemcitabine/nab-Paclitaxel in First Line Pancreatic Cancer as of December 5, 2024

As of December 5, 2024, three patients in the Phase 2a arm evaluating IMM-1-104 with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer achieved complete or partial responses for an overall response rate of 43% (3/7) and disease control rate of 86% (6/7). Four patients remain on treatment.
Benchmarks for gemcitabine/nab-paclitaxel alone in first-line pancreatic cancer patients were established by the Phase 3 MPACT study, which included 1 Complete Response (CR) out of 431 patients, a 23% Overall Response Rate, and a 48% Disease Control Rate1. Benchmarks for modified (m) Gemcitabine/nab-Paclitaxel, the less intensive regimen utilized in the IMM-1-104 Phase 2 combination arm, include an 18.6% ORR2.
A favorable tolerability profile was observed for IMM-1-104 in combination with modified Gemcitabine/nab-Paclitaxel.
[1] Von Hoff, et al. N Engl J Med 2013;369:1691-1703, [2] Ahn DH, et al. Therapeutic Advances in Medical Oncology. 2017;9(2):75-82

"Immuneering’s Phase 2a data in first-line pancreatic cancer are very promising," said Tanios Bekaii-Saab, M.D., Leader of the Gastrointestinal Cancer Disease Group for the Mayo Clinic Cancer Center enterprise-wide and Medical Oncology consultant in Mayo Clinic in Phoenix, Arizona. "If current trends continue, the combination of IMM-1-104 with modified gemcitabine/nab-paclitaxel may provide improved efficacy and tolerability versus gemcitabine/nab-paclitaxel in the first-line pancreatic cancer setting, where patients continue to urgently need better options. In addition, having a MEK inhibitor that appears to be as well-tolerated as IMM-1-104 may provide new opportunities for patients with different types of cancer."

Initial Data from Phase 2a Arm Evaluating IMM-1-104 with Modified FOLFIRINOX in First Line Pancreatic Cancer as of December 5, 2024

As of December 5, 2024, all evaluable patients (n=4) experienced target tumor shrinkage and disease control, with one patient achieving a 100% reduction (PR).
The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated.
The Company is currently evaluating the 320 mg QD dose of IMM-1-104 in combination with modified FOLFIRINOX.
Initial Data from Phase 2a Arm Evaluating IMM-1-104 Monotherapy in Second Line Pancreatic Cancer as of December 5, 2024

"Having demonstrated compelling activity in both the combination and monotherapy settings for pancreatic cancer, the emerging tolerability profile for IMM-1-104 is also highly promising," said Brett Hall, Ph.D., Chief Scientific Officer, Immuneering Corporation. "Looking at the table of treatment-related adverse events observed in greater than 10% of patients in our monotherapy arm, no Grade 3 or Grade 4 events were observed, and only a handful of Grade 2 events were observed. The maturing safety profile for IMM-1-104 gives us confidence that Immuneering may have developed a better tolerated MEK-inhibitor, with exciting potential for vertical, immune-modifying, and orthogonal combinations. We expect to share expanded development plans for IMM-1-104 beyond pancreatic cancer, as we continue to explore options with investigators and third parties."

As of December 5, 2024, eleven of the twenty-one evaluable patients treated in the Phase 2a arm assessing IMM-1-104 as monotherapy in second-line pancreatic cancer achieved disease control, including one patient with 67% target lesion shrinkage (PR). Nine patients remain on treatment.
IMM-1-104 monotherapy was observed to be very well tolerated in second-line pancreatic cancer patients, suggesting that IMM-1-104 may be highly suitable for both monotherapy and combination therapy.
Immuneering previously announced that IMM-1-104 received Fast Track designation from the FDA for the treatment of first- and second-line pancreatic cancer, along with orphan drug designation. The FDA also recently granted Fast Track designation for IMM-1-104 as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. Today’s data update follows initial data that was presented in September 2024 on the trial’s arm studying IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer.

Today, Immuneering also announced initial pharmacokinetic, pharmacodynamic and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415. To date, IMM-6-415 has demonstrated its potential to induce Deep Cyclic Inhibition, and in doing so has been well tolerated – consistent with what was observed preclinically for the development candidate.

Near-Term Milestone Expectations

IMM-1-104

Further IMM-1-104 Phase 2a data expected in the second quarter of 2025
Initiation of Phase 2a arm of IMM-1-104 in combination with BRAF inhibitor in melanoma planned for 2025
Initiation of Phase 2a arms of IMM-1-104 in combination with checkpoint inhibitors in both melanoma and NSCLC planned for 2025
Conference Call

Immuneering will host a conference call and live webcast at 8:30 a.m. ET / 5:30 a.m. PT on January 7, 2025, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 4497245, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

On January 7, 2025 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy (Press release, GlaxoSmithKline, JAN 7, 2025, View Source [SID1234649466]). The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy.1 This is the third regulatory designation for GSK’227, following the European Medicines Agency’s decision to grant Priority Medicines (PRIME) designation and the FDA’s decision to grant Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.2,3

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "This latest regulatory designation for GSK’227 exemplifies the potential of our targeted ADC in patients with difficult to treat cancers. For patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns a second time, and chemotherapy provides limited benefit in this setting."

The US FDA’s Breakthrough Therapy Designation is supported by data from the ARTEMIS-002 study. This is a phase II, open-label, randomised, multi-centre, clinical trial evaluating the efficacy and safety of GSK’227 in patients with relapsed or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas, conducted by Hansoh Pharma. More than 60 patients were enrolled, including 42 patients with osteosarcoma. Results from ARTEMIS-002 were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.4 Last year, GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of GSK’227. GSK recently began a global phase I trial (NCT06551142) as a part of the development plan to support a registrational pathway for GSK’227.

Osteosarcoma mainly affects children and young adults and is the most common primary bone cancer, accounting for 20-40% of all bone cancers.5 It is a rare disease with an annual incidence of 3.3 patients per million in the US, representing less than 1% of all new cancer diagnoses.6,7 Approximately 20-30% of patients who present with localised (non-metastatic) osteosarcoma and 80% of those who present with metastatic osteosarcoma experience relapsed or refractory disease.8 Following first-line chemotherapy, treatment options for patients with relapsed or refractory osteosarcoma are severely limited, with no clear standard of care available.9 After patients progress on two prior lines of treatment, options become even more limited, with no approved therapies.

About GSK’227
GSK’227, also known as HS-20093, is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. HS-20093 is being developed by Hansoh Pharma for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I, II and III clinical trials in China. GSK’s global phase I trial for GSK’227 began in August 2024.

On January 7, 2025 Eli Lilly and Company (NYSE: LLY) reported that it will attend the 43rd Annual J.P. Morgan Healthcare Conference, Jan. 13-16, 2025. David A. Ricks, Lilly chair and CEO, will participate in a fireside chat on Tuesday, Jan. 14 at 5:15 p.m. Eastern time (Press release, Eli Lilly, JAN 7, 2025, View Source [SID1234649465]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 30 days.

On January 7, 2025 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that Richard A. Miller, M.D., president and chief executive officer, will conduct one-on-one meetings with investors and present a corporate overview at the 43rd Annual J.P. Morgan Healthcare Conference, which is being held in San Francisco from January 13-16, 2025 (Press release, Corvus Pharmaceuticals, JAN 7, 2025, View Source [SID1234649464]). The Company’s presentation will be on Wednesday, January 15 at 2:15 pm ET / 11:15 am PT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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An audio webcast of the presentation will be available live and for 30 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

On January 7, 2025 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary, Citius Oncology (Nasdaq: CTOR), reported significant progress in preparations for the commercial launch of LYMPHIR, an innovative immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Press release, Citius Pharmaceuticals, JAN 7, 2025, View Source [SID1234649462]). Management is focused on making LYMPHIR available to patients as quickly as possible, with preparations underway for launch in the first half of 2025.

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"Since LYMPHIR’s approval in August 2024, we have worked diligently toward supporting its successful launch. We are making significant progress to finalize our manufacturing, marketing, reimbursement and sales efforts. This is a pivotal inflection point as we transition from clinical development to revenue generation. Our strategy not only focuses on a successful U.S. market penetration, but also includes exploring additional growth opportunities, including licensing partnerships in key international markets, for which discussions are underway, expanded indications for LYMPHIR, in addition to LYMPHIR’s potential as a combination immunotherapy. Our unwavering goal remains to deliver substantial value to patients, healthcare providers, and shareholders by bringing this innovative cancer treatment to market," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology.

Key Launch Preparations and Activities:

● Manufacturing Scale-Up and Supply Chain Optimization:

o Secured commercial supply agreements with leading contract manufacturing organizations (CMOs).

o First Year Launch Supply has been produced.

● Healthcare Provider Engagement:

o Rolled out targeted education programs aimed at oncologists, hematologists, and other key medical professionals.

o Launched an information platform that offers clinical data, dosing guidelines, and safety information for healthcare providers.

● Market Access and Reimbursement Efforts:

o Working closely with payers and healthcare providers to secure reimbursement pathways that facilitate patient access.

o Submitted an application for a unique J-code under the Healthcare Common Procedure Coding System (HCPCS) to streamline reimbursement processes.

o Secured LYMPHIR’s inclusion in the National Comprehensive Cancer Network (NCCN) guidelines, a key factor in influencing clinical decision-making and payer coverage in the U.S.

● Patient Support Initiatives:

o Designed a patient assistance program to help with financial support and access to LYMPHIR.

o Developing a best-in-class patient services center to assist LYMPHIR patients with administrative and prescribing needs.

● Marketing and Sales Initiatives:

o Launched a core marketing campaign to raise awareness among healthcare providers, ensuring that top CTCL prescribers are informed of LYMPHIR’s availability.

o Building an experienced specialized field sales team to partner with CTCL providers and office staff.

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 fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR 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 Sézary 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.

INDICATION

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 therapy.

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 occurred.

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 to 3 g/dL.

Visual Impairment

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.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management.

Hepatotoxicity

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

Risk Summary

No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

Females and Males of Reproductive Potential

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males

Based on findings in rats, male fertility may be compromised by treatment with. The reversibility of the effect on fertility is unknown.

Pediatric Use

Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

Geriatric Use

Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Pharmaceuticals at 1-844-459-6744.

Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.