On May 21, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the new drug application (NDA) for toripalimab in combination with disitamab vedotin for patients with HER2-expressing (which is defined as achieving a score of 1+, 2+ or 3+ in HER2 immunohistochemistry test), locally advanced or metastatic urothelial carcinoma (UC) was approved by the National Medical Products Administration (NMPA). Disitimab vedotin is an antibody drug conjugate independently developed by RemeGen Co., Ltd. With this latest approval, toripalimab injection now has 13 approved indications in the Chinese Mainland.

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UC is among the top ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths exceeded 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.

In 2021, toripalimab injection was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective population-based indications of advanced UC in China.

The approval of this new indication is based on results from the RC48-C016 study (NCT05302284). The study is a multi-center, randomized, open-label and controlled phase 3 clinical trial which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing (which is defined as HER2 IHC 1+, 2+ or 3+) locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators.

In October 2025, the study results of RC48-C016 were published in The New England Journal of Medicine (NEJM), and shared in an oral presentation at the Presidential Symposium of the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting (#LBA7).

The results were positive for both primary endpoints, progression free survival ("PFS", assessed by blinded independent review) and overall survival ("OS"). Compared with traditional chemotherapy, toripalimab in combination with disitamab vedotin for the first-line treatment of HER2-expressing advanced UC more than doubled the median PFS [13.1 months vs. 6.5 months, hazard ratio (HR)=0.36, 95%CI: 0.28-0.46; p<0.0001], as well as the median OS (31.5 months vs. 16.9 months, HR=0.54, 95%CI: 0.41-0.73; p<0.0001). The objective response rate (ORR) greatly increased (76.1% vs. 50.2%) and the medium duration of response (DoR) almost tripled in comparison (14.6 months vs. 5.6 months). The combination therapy group also demonstrated significant improvements in safety compared to the chemotherapy group.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "The approval of toripalimab’s 13th indication is a huge milestone for us all, and sheds light on the importance of our open collaboration R&D strategy. In urologic oncology immunotherapy, toripalimab continues to be a driving force and this approval deepens its impact across the immunotherapy landscape. We are immensely proud to partner with RemeGen. Together, we were able to combine two locally-developed innovations to create a powerful synergistic treatment that significantly improves both PFS and OS. Moving forward, Junshi Biosciences will expand on our Immuno-Oncology (I-O) 2.0 strategy, pursuing the next generation of combination therapies and novel target drugs to fulfill our commitment to enduring innovation, ensuring China’s innovation benefits global patients."

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are twelve approved indications for toripalimab in the Chinese mainland:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma (UC) that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);
in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;
first-line treatment for unresectable or metastatic melanoma;
in combination with disitamab vedotin for the first-line treatment of HER2 expressing UC.

The first 12 indications have been included in the National Reimbursement Drug List (NRDL) (2025 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, RCC and TNBC. Toripalimab for the treatment of advanced NPC and ESCC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in more than 40 countries and regions including the United States, the European Union, India, the United Kingdom, Australia and Singapore, and is also under review for marketing in various countries and regions worldwide.

(Press release, Shanghai Junshi Bioscience, MAY 21, 2026, View Source [SID1234665994])

On May 21, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in AL Amyloidosis, reported that all four relapsed/refractory AL Amyloidosis MRD-negative patients presented at ASH (Free ASH Whitepaper) 2025 have converted to complete response (CR). The NEXICART-2 CR rate is now 95% (19 out of 20 patients). All CRs were reached within 1 year of follow-up post-dosing. No relapses have been observed as of today for patients who have reached CR. All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month. The next NEXICART-2 update is expected late September 2026.

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These results support the Company’s plan to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients.

"Even in a heavily pretreated population of median 4 prior lines of therapy, we are pleased that NXC-201, as a 5th line of therapy, drives MRD-negativity, converting to durable CRs to-date, indicating that NXC-201 can eliminate the source of toxic light chains that clog up the heart, kidney and liver, causing organ failure and death in relapsed/refractory AL Amyloidosis. As a potential frontline therapy in AL Amyloidosis, we believe there’s potential to transform a usual 2-year treatment, into a one-and-done: NXC-201." Gabriel Morris, President, Chief Financial Officer of Immix Biopharma, added, "We have observed the NEXICART-2 CR rate improving over time. In September 2026 we plan to present updated data from our ongoing NEXICART-2 trial. By end of March 2027, we expect to present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch."

About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 45-patient study.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research as of 2023.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, MAY 21, 2026, View Source [SID1234665931])

On May 21, 2026 Orion Pharma (Orion Corporation) reported that for the first time it will present clinical data from the ongoing Phase 1/2 TEADES trial evaluating ODM-212, an investigational oral small-molecule pan-TEAD inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, USA.

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The TEADES study is a multi-center, open-label, first-in-human trial designed to evaluate the safety, tolerability and preliminary anti-tumour activity of ODM-212 in patients with advanced solid tumours, including tumour types characterized by dysregulation of the Hippo pathway, such as mesothelioma and epithelioid hemangioendothelioma (EHE).

Details of the presentation are as follows:

Title: First-in-human trial of the TEAD inhibitor ODM-212 in patients with advanced solid tumours (TEADES)
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology (Hall A)
Abstract number: 3111
Presentation date/time: May 30, 2026, 1:30 – 4:30 PM CDT
Data from the phase 1 study will be presented during the conference.

"The upcoming presentation at ASCO (Free ASCO Whitepaper) marks an important milestone for ODM-212, our clinical-stage TEAD inhibitor," says professor Outi Vaarala, Executive Vice President, Research & Development, Orion Pharma. "We look forward to sharing initial data from the TEADES study, which will inform the ongoing development of ODM-212 for patients with advanced solid tumours with high unmet medical need."

About the TEADES study
The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction of the Hippo pathway. The trial includes patients who have progressed despite available standard treatmentsand with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway,particularly through YAP/TAZ activation,can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, MAY 21, 2026, View Source [SID1234665947])

On May 21, 2026 Lunit, a leading provider of AI for cancer diagnostics and precision oncology, reported that five studies featuring its AI biomarker platforms are being presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago, IL.

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This year’s presentations reflect Lunit’s expanding biomarker research beyond conventional immune profiling toward integrated AI-powered HER2/IHC biomarker quantification and spatial tumor microenvironment (TME) analysis. Using AI to characterize HER2 expression, immune phenotypes, tertiary lymphoid structures (TLS), tumor-infiltrating lymphocytes (TILs), and endothelial cells, the studies highlight the potential of integrated biomarker analysis to improve precision patient stratification across multiple cancer types.

The five presentations include studies across biliary tract cancer (BTC), non-small cell lung cancer (NSCLC), adenoid cystic carcinoma (ACC), microsatellite-stable (MSS), metastatic colorectal cancer and advanced gastric cancer (AGC).

One of the featured studies, led by researchers at Yonsei University College of Medicine, evaluates a first-line quadruplet regimen consisting of trastuzumab, nivolumab, gemcitabine, and cisplatin in HER2-positive advanced BTC. The study is selected as a Rapid Oral Presentation at ASCO (Free ASCO Whitepaper) 2026.

Using AI-powered whole-slide image (WSI) analysis, researchers analyze HER2 expression and immune phenotypes within tumor tissue. Among 40 patients enrolled in the multi-center phase Ib/II trial, the combination of therapy demonstrates an objective response rate (ORR) of 55%, disease control rate (DCR) of 95%, and median progression-free survival (PFS) of 10.6 months. Patients with HER2 IHC 3+ tumor cell proportions ≥10%, as identified by AI analysis, achieve substantially higher response rates compared to those below the threshold (80% vs. 36.4%). The study demonstrates how integrated AI-powered HER2 and spatial tumor microenvironment analysis may help identify patients more likely to benefit from HER2-targeted combination therapies.

Another study characterizes the tumor microenvironment landscape of HER2-overexpressing NSCLC using AI-powered spatial analysis. Across more than 2,000 NSCLC whole-slide images, HER2-overexpressing tumors demonstrate significantly reduced tumor-infiltrating lymphocyte density and lower proportions of inflamed immune phenotype compared to non-overexpressing tumors. The immune-cold phenotype becomes more pronounced in tumors with higher proportions of HER2 3+ cells. The study provides additional insight into the biological relationship between HER2 overexpression and tumor immune status, while highlighting the broader potential of combining AI-powered HER2 analysis with spatial tumor microenvironment characterization in biomarker research.

Another featured study, conducted with Seoul National University Hospital, explores AI-powered spatial tumor microenvironment analysis in adenoid cystic carcinoma (ACC), a rare cancer with limited treatment options. Researchers identify a subgroup of ACC patients with high endothelial cell and tumor-infiltrating lymphocyte (TIL) densities who demonstrate significantly prolonged progression-free survival following axitinib treatment (19.6 months vs. 11.1 months). The findings suggest that AI-based spatial profiling may help distinguish responder populations that are difficult to stratify using conventional biomarkers alone.

Researchers at Asan Medical Center investigate AI-powered tumor microenvironment analysis in MSS metastatic colorectal cancer, which is generally considered resistant to immune checkpoint inhibitors (ICIs). Researchers find that patients with larger tertiary lymphoid structure (TLS) regions identified by AI demonstrate improved progression-free survival and overall survival following immunotherapy. The findings highlight the potential of AI-powered spatial analysis to identify MSS colorectal cancer patients more likely to benefit from immunotherapy.

"These studies demonstrate how AI-powered biomarker analysis is evolving beyond conventional immune profiling toward integrated HER2/IHC quantification and spatial tumor microenvironment analysis," said Brandon Suh, CEO of Lunit. "We believe integrated biomarker analysis will play an increasingly important role in precision oncology research, patient stratification, and treatment-response assessment."

Lunit will be exhibiting at ASCO (Free ASCO Whitepaper) 2026, where attendees can learn more about the company’s AI biomarker platforms and research collaborations.

(Press release, Lunit, MAY 21, 2026, View Source [SID1234665963])

On May 21, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that new research evaluating PEDMARK (sodium thiosulfate injection) across multiple patient populations and tumor types will be shared as part of the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting program.

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These four independently led studies build upon the established safety and efficacy of PEDMARK – currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients – and help to expand understanding of the clinical utility of PEDMARK in Adolescent and Young Adult (AYA) and adult populations, where significant unmet need remains.

"Cisplatin-induced ototoxicity (CIO), or permanent hearing loss related to cisplatin chemotherapy, is increasingly recognized as a major survivorship issue in oncology," said Koral Shah, MD, study investigator, presenter at ASCO (Free ASCO Whitepaper) and Hematology/Oncology Chief Fellow at City of Hope. "There is a growing interest among physicians, multidisciplinary care teams, and patients to identify strategies that may reduce long-term treatment-related toxicities and to integrate these new approaches into clinical practice. Importantly, this work reflects a broader shift in oncology — one that extends beyond tumor response alone and prioritizes survivorship and long-term quality of life. Cure is not always the end of the story. As survivorship improves, ensuring patients not only live longer but also live well is critical."

Randomized Phase 1 Trial of Cisplatin-Based Chemotherapy With or Without Sodium Thiosulfate for Men with Metastatic Germ Cell Tumor (GCT) Abstract #: TPS5131
Dr. Shah will present the trial design for a randomized Phase 1 study of cisplatin-based chemotherapy with or without sodium thiosulfate (PEDMARK) for men with metastatic germ cell tumors (GCT) that was opened to accrual by City of Hope in January of 2026. Among adult GCT survivors, approximately 75 percent develop hearing loss, with severity associated with cumulative cisplatin exposure.

Effects of Delayed Sodium Thiosulfate on Cisplatin-Induced Ototoxicity in Pediatric and Adolescent Patients with Cancer: Results from the Japanese Children’s Cancer Group STS-J01 Study Abstract #: 10052
Detailed results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK for the reduction of CIO in pediatric and AYA patients with non-metastatic solid tumors in Japan will be presented by Eiso Hiyama, MD, professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan. The study, which enrolled 27 patients, met its primary endpoint with a significant reduction in hearing loss in 3–18-year-old patients who received PEDMARK when compared with historically reported rates of hearing loss in patients receiving cisplatin alone (16-24% versus 56-63%, respectively).

Real-world Feasibility and Tolerability of PEDMARK for Otoprotection in Young Adults Receiving Cisplatin for Solid Tumors Abstract #: e24189
Veronica Alana Vestal, MD, of the Comprehensive Cancer Center of the University of Puerto Rico will share a retrospective case series including nine patients aged 18-39 years old with localized solid tumors that demonstrate that PEDMARK can be feasibly incorporated into AYA and Adult oncology workflows and does not interfere with cisplatin’s antitumor activity.

Audiometric Outcomes for Intravenous Sodium Thiosulfate for Cisplatin-Induced Ototoxicity Prevention in Adults with Head and Neck Cancer Abstract 3: e18110
Real world data supporting potential use of PEDMARK (sodium thiosulfate injection) in adults with head and neck cancers will be published by Leslie Worona, FNP-BC, OCN, oncology nurse practitioner and James Johns, MD at Mount Sinai Hospital. Findings from the multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK could be safely given ≥six hours after cisplatin dosing, was easy to incorporate into the real-world care plan for adults with HNC and was associated with preservation of clinically significant hearing.

"Collectively, these studies represent an important step forward in addressing a critical unmet need and highlight the potential for PEDMARK to meaningfully impact patient care more broadly. At the same time, significant gaps and opportunities remain. Adolescent and young adult as well as adult patients continue to face a similar burden, yet prospective data in these populations are still emerging," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "The research being shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting reflects Fennec’s ongoing commitment to expanding the evidence base supporting use and integration of PEDMARK to prevent cisplatin induced ototoxicity in additional patient populations and tumor types."

The full abstracts are also available on the ASCO (Free ASCO Whitepaper) website.

About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.1

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy2. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.3 Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)
PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.89

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, MAY 21, 2026, View Source [SID1234665979])