Arokaris (fosnetupitant) / Helsinn, Otsuka - LARVOL DELTA

Design of a single-institution prospective observational study to evaluate the efficacy and tolerability of four-drug antiemetic therapy for anthracycline-based chemotherapy for early breast cancer (SG-BCC 2025) - "Goals: The aim is to present our study design to evaluate the efficacy, tolerability of the co-administration of 4 drugs {fosnetupitant (FosNTP), palonosetron (PALO), dexamethasone (DEX) and olanzapine (OLZ)} to prevent chemotherapy-induced nausea and vomiting (CINV) in early breast cancer (EBC) patients (pts) treated with anthracycline-based (neo)adjuvant chemotherapy {(N)ACT}. For prophylaxis of CINV induced by highly emetogenic chemotherapy, several guidelines recommend the multiple use of targeted prophylactic drugs including neurokinin 1 receptor-antagonists (RA), 5-hydroxytryptamine-3 RA in combination with DEX, and OLZ. However, despite OLZ contribute to CINV prophylaxis owing to its antidopaminergic, antiserotonergic and anticholinergic properties, OLZ has some characteristic side effects such as somnolence that negatively impact the quality of life of EBC pts. The research question of our study is whether novel four-drug antiemetic therapy (FosNTP, PALO, DEX..."

Clinical • Observational data • Breast Cancer • Oncology • Solid Tumor

Safety and Feasibility of Outpatient Zolbetuximab Administration in Community Cancer Care: A Mixed-methods Analysis. (PubMed, In Vivo) - "Outpatient zolbetuximab administration proved safe and feasible in a community setting when implemented with appropriate protocols and support systems. This implementation model could serve as a template for delivering complex cancer therapies in resource-limited settings."

Journal • Gastric Cancer • Oncology • Solid Tumor • CLDN18

Cost-effectiveness analysis of Fosnetupitant, an NK1 Receptor Antagonist, Compared to Fosaprepitant and Aprepitant (JSMO 2025) - No abstract available

Cost effectiveness • HEOR • Oncology

A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 Mg and Metabolites in Healthy Volunteers (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: Helsinn Healthcare SA

New P1 trial

Cost-effectiveness analysis of fosnetupitant in patients receiving cisplatin in Japan: analysis based on real-world data. (PubMed, Support Care Cancer) - "F-NTP is more cost-effective than F-APR, but slightly less cost-effective than APR."

Clinical • HEOR • Journal • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting

Safety of a short-term infusion of fosnetupitant in patients with gastrointestinal and breast cancer: a prospective study. (PubMed, Oncologist) - "Short-term infusion of fosnetupitant, administered over 15 minutes, was demonstrated to be safe and effective for patients receiving HEC or MEC (Japan Registry of Clinical Trials Trial ID: jRCT1041220144)."

Journal • Allergy • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Gastrointestinal Disorder • Oncology • Solid Tumor

Effects of antiemetics on perioperative EC therapy for breast cancer (JBCS 2024) - "Prophylactic antiemetic therapy was administered in combination with dexamethasone, palonosetron as a 5-HT3 receptor antagonist, and aprepitant, fosaprepitant, and fosnetupitant as NK1 receptor antagonists, based on the 2015 Antiemetic Guidelines. Acute nausea and additional antiemetics were often administered in the evening of the day of infusion. The revised 2023 Antiemetic Guidelines recommend that patients with a high emetic risk take olanzapine after dinner on day 1, but we believe that prophylactic antiemetic therapy with olanzapine for EC therapy should be administered earlier than after dinner"

Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Report on a follow-up study after prophylactic administration of fosnetupitant to patients undergoing dose-dense EC therapy at our hospital (JBCS 2024) - "On the other hand, EC therapy (epirubicin + cyclophosphamide), which is positioned as a high emetogenic risk regimen (Japan Society of Clinical Oncology Antiemetic Appropriate Use Guidelines, October 2023, revised 3rd edition), like cisplatin regimens, has only been verified in a study (CONSOLE-BC study) with safety as the primary endpoint, and its efficacy has not been clarified...Method We investigated the occurrence of nausea and vomiting associated with the initial treatment in patients who received fosnetupitant under palonosetron and dose-dense EC therapy from April 2022 to October 2023... Eight patients were surveyed, with a median age of 50.5 years at the time of treatment. Two patients were treated preoperatively and six were treated postoperatively. One patient (12.5%) experienced vomiting throughout the entire period, and its onset was in the very delayed phase."

Clinical

Treatment experience of trastuzumab deruxtecan (T-DXd) for HER2-positive and low-expressing advanced recurrent breast cancer at our hospital (JBCS 2024) - "Four patients received an additional dose of fosnetupitant 235 mg, and one of these patients received an additional dose of olanzapine 5 mg. The median age at the time of first administration was 66 years (range 48-86 years). Four patients were HER2 positive (one ER positive, three ER negative), and three were HER2 low expressing (all ER negative). Two patients had metastatic recurrence and five had de novo disease."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ER • HER-2

A study of cases of Enhertz administration for HER2 low expression, metastatic recurrent breast cancer at our hospital (JBCS 2024) - "The average period from the start of treatment to T-DXd administration was 62.6 months, and 5.7 regimens...Oral administration of Novamin, Zyprexa, and Serenece was not effective enough...Fosnetupitant was added to cases where nausea and vomiting could not be controlled with prednisone and palonosetron, and it was effective. 5 cases of de novo stage IV and 5 cases of postoperative distant organ metastasis, average age 60.4 years. Nine cases were luminal type, and one was near TN type. Re-biopsy was performed in two local cases and two liver cases, and two cases had blocks ordered from the previous doctor."

Clinical • Metastases • Anorexia • Breast Cancer • Fatigue • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

A study of the use of fosnetupitant in highly emetogenic chemotherapy (HEC) (JBCS 2024) - "From the patient's perspective, the most painful side effect is said to be nausea and vomiting (CINV), and triple combination therapy (NK-1 receptor inhibitor, 5-HT3 receptor inhibitor, dexamethasone) is recommended as supportive therapy when performing highly emetogenic chemotherapy (HEC)...[Results] Age of the FNP group was 51-69 years (mean 60 years), motion sickness (+) in 3/9, alcohol use (+) in 4/9, previous treatment (+) in 3/9, chemotherapy was NAC in 6 cases, and with 3 cases of progression or recurrence, dose-dense EC in 5 cases, EC+pembrolizumab in 1 case, EC in 1 case, FEC in 1 case, and trastuzumab-deruxtecan in 1 case...Conclusion Fosnetupitant was useful due to its efficacy, reduced medication burden, and no injection site side effects. We plan to continue to increase the number of cases and conduct further studies"

Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Constipation • Dental Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Solid Tumor • Stomatitis

INDIVIDUAL PATIENT DATA META-ANALYSIS OF NEPA VS. APREPITANT ANTIEMETIC REGIMENS IN THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) (MASCC-AFSOS-ISOO 2024) - "We included published randomized controlled trials that compared aprepitant/fosaprepitant (in combination with any 5-HT3RA agent and dexamethasone) with netupitant/fosnetupitant (in combination with palonosetron and dexamethasone [NEPA]) given as CINV prophylaxis to patients with cancer receiving HEC or MEC. Conclusions These IPD meta-analysis findings indicate that NEPA-based regimens offer greater protection from CINV than aprepitant regimens, especially on Days 3-5 (days established as risk factors for CINV beyond 120h). This makes NEPA-based regimens particularly promising for managing the extended duration of CINV associated with emerging anticancer targeted therapies, such as antibody drug conjugates, among others."

CINV • Retrospective data • Chemotherapy-Induced Nausea and Vomiting • Oncology

Comparing the Efficacy of Fosnetupitant, an NK1 Receptor Antagonist in CDDP-Based Regimens, With that of Fosaprepitant and Aprepitant: A Retrospective Observational Study. (PubMed, Biol Pharm Bull) - "In this retrospective case-control study involving patients receiving cisplatin-containing regimens and neurokinin 1 receptor antagonists, patients were divided into three groups based on prophylactic antiemetic therapy: F-NTP, F-APR, and APR. Prophylactic antiemetic therapy, including F-NTP, was effective and well-tolerated during the delayed period. The efficacy of F-NTP in managing chemotherapy-induced nausea and vomiting was superior to those of F-APR and APR during the study period."

Journal • Observational data • Retrospective data • Chemotherapy-Induced Nausea and Vomiting • Oncology

Safety of a Short-Term Infusion of fosnetupitant in patients with gastrotiontinal and breast Cancancer (JSMO 2024) - No abstract available

Clinical • Breast Cancer • Oncology

Pooled Analysis of Studies Evaluating Fosnetupitant and Risk Factors for Cisplatin-Induced Nausea and Vomiting During the Extended Overall Phase. (PubMed, Adv Ther) - "This analysis revealed that fosnetupitant could have long-acting antiemetic potency (> 120 h) and indicated the importance of antiemetic therapy at 0-120 h for CINV up to 168 h after chemotherapy."

Journal • P3 data • Retrospective data • Chemotherapy-Induced Nausea and Vomiting

Real-World Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-Based Chemotherapy. (PubMed, Adv Ther) - "In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy."

HEOR • Journal • Real-world • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting • Oncology

POOLED ANALYSIS OF FOSNETUPITANT-EVALUATED STUDIES AND RISK FACTORS FOR CISPLATIN-INDUCED NAUSEA AND VOMITING DURING THE EXTENDED OVERALL PHASE (MASCC-JASCC-ISOO 2023) - "This study assessed the efficacy of FosNTP in combination with palonosetron and dexamethasone and identified risk factors for chemotherapy-induced nausea and vomiting (CINV) for up to 168 h after treatment using pooled data from Japanese studies. Methods A pooled analysis of randomized phases II and III studies was performed to compare the efficacy of FosNTP and fosaprepitant (FosAPR) in patients receiving cisplatin-based chemotherapy...The CINV risk factor at 120–168 h was treatment failure in the first 120 h. TTF deteriorated as the number of identified CINV risk factors increased. Conclusions This analysis revealed that FosNTP has significantly greater antiemetic potency than FosAPR and indicated the importance of antiemetic therapy up to 168 h after chemotherapy including consideration of CINV risk factors."

Retrospective data • Chemotherapy-Induced Nausea and Vomiting

Survey of fosnetupitant for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based chemotherapy (JSMO 2023) - No abstract available

CINV • Clinical • Chemotherapy-Induced Nausea and Vomiting

Fosnetupitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Short Review and Clinical Perspective. (PubMed, Adv Ther) - "Fosnetupitant is one of the standard treatments for the prevention of CINV in patients who are receiving highly (any treatment where CINV occurs in more than 90% of patients) or moderately (where CINV occurs in 30-90% of patients) emetogenic chemotherapies. The aim of this commentary is to describe the mechanism of action, tolerability, and antiemetic efficacy of single-agent fosnetupitant in the prevention of CINV, and to discuss its clinical application, in order to aid optimal use."

CINV • Journal • Review • Chemotherapy-Induced Nausea and Vomiting

Challenges in the Development of Intravenous Neurokinin-1 Receptor Antagonists: Results of a Safety and Pharmacokinetics Dose-Finding, Phase 1 Study of Intravenous Fosnetupitant. (PubMed, Clin Pharmacol Drug Dev) - "A fosnetupitant 235-mg dose was equivalent, in terms of netupitant exposure, to 300-mg oral netupitant. The safety profile of a single fosnetupitant 235-mg infusion was similar to that of single-dose oral NEPA."

Journal • P1 data • PK/PD data • Cardiovascular • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Pain • Thrombosis

Netupitant-Palonosetron (NEPA) in Preventing Chemotherapy-Induced Nausea and Vomiting: From Clinical Trials to Daily Practice. (PubMed, Curr Cancer Drug Targets) - "NEPA is the first and only fixed combination antiemetic, composed of netupitant (oral)/fosnetupitant (intravenous) and palonosetron, which, together with dexamethasone, constitute a triple antiemetic combination recommended for the prevention of CINV for patients receiving highly emetogenic chemotherapy and for certain patients receiving moderately emetogenic chemotherapy. This review provides an overview of CINV, evaluates the accumulated evidence of NEPA's antiemetic activity and safety from clinical trials and real-world practice, and examines the preliminary evidence of antiemetic control with NEPA in daily clinical settings beyond those described in pivotal trials. Moreover, we review the utility of NEPA in controlling nausea and preserving patients' quality of life during chemotherapy, two major concerns in managing patients with cancer."

CINV • Journal • Chemotherapy-Induced Nausea and Vomiting • Oncology

MANAGEMENT OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV)-RESULTS FROM A FOSNETUPITANT STUDY FOR BREAST CANCER PATIENTS (GBCC 2022) - " Patients scheduled to receive AC/EC were randomized 1:1 to receive FosNTP 235 mg or FosAPR 150 mg both in combination with intravenous palonosetron 0.75 mg and dexamethasone 9.9 mg on day 1. FosNTP demonstrated a favorable safety profile, with a very low risk of ISRs in the AC/EC setting."

CINV • Clinical • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Dermatology • Oncology • Pain • Solid Tumor • Urticaria

Taiho Pharmaceutical Obtains Approval to Manufacture and Market NK1 Receptor Antagonist Arokaris I.V. Infusion 235mg in Japan (GlobeNewswire) - "Taiho Pharmaceutical Co., Ltd...announced today that Taiho has been granted approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market the NK1 receptor antagonist antiemetic drug “Arokaris® I.V. Infusion 235mg” (generic name: fosnetupitant chloride hydrochloride) for gastrointestinal symptoms (nausea and vomiting, including delayed phase) associated with cancer chemotherapy (cisplatin, etc.)...This approval is based on the results of a Phase III clinical study (CONSOLE6) comparing the efficacy and safety of Arokaris® versus fosaprepitant in patients receiving highly emetogenic chemotherapy in combination with palonosetron and dexamethasone."

Japanese regulatory • Oncology

Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE). (PubMed, Oncol Ther) - "In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy."

CINV • Clinical • Journal • P3 data • Chemotherapy-Induced Nausea and Vomiting

Alleviating Chemo-Related Nausea Is a Huge Unmet Need (Medscape) - "This is Mark Kris from...that reported a study of a new neurokinin-1 antagonist called fosnetupitant. This was a well-conducted trial that demonstrates the noninferiority of IV fosnetupitant when compared with IV fosaprepitant. By their study criteria, fosnetupitant was not inferior."

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