palonosetron intravenous / Generic mfg. - LARVOL DELTA

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P3 | N=72 | Active, not recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Renal Disease

Results of a Special Drug Use-Results Survey on Palonosetron Hydrochloride in Patients Aged 18 Years and Younger (PubMed, Gan To Kagaku Ryoho) - "A special drug use-results survey was conducted in patients aged 18 years and younger to assess the occurrence of adverse drug reactions, and the safety and efficacy of palonosetron hydrochloride(Aloxi I. V. Injection 0.75 mg/Aloxi I. V. Infusion Bag 0.75 mg)in multiple-course administration in Japan...No decrease in CR rate was also observed even after multiple-course administration. Based on these results, the safety and efficacy of palonosetron hydrochloride in practice do not appear to be any major issues."

Journal

Comparative Analysis of Oliceridine versus Sufentanil in Gastrointestinal Endoscopy for Geriatric Patients (ChiCTR) - P4 | N=198 | Not yet recruiting | Sponsor: Jinjiang Municipal Hospital; Jinjiang Municipal Hospital

New P4 trial • Geriatric Disorders

Overall efficacy and safety of olanzapine 5 mg added to triplet antiemetics for an anthracycline-containing regimen in patients with breast cancer: a phase 3, double-blind, randomised, placebo-controlled trial. (PubMed, Lancet Oncol) - "Post-chemotherapy administration of 5 mg olanzapine in combination with triplet antiemetic therapy before anthracycline plus cyclophosphamide-based chemotherapy significantly improved the complete response rate for chemotherapy-induced nausea and vomiting during the overall phase compared with placebo in female patients with breast cancer receiving outpatient chemotherapy, with an acceptable level of safety. The findings represent a substantial advancement in managing chemotherapy-induced nausea and vomiting and provide assurance that the safe and effective administration of olanzapine can be achieved at a dosage of 5 mg."

Journal • P3 data • Anesthesia • Anorexia • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Solid Tumor

When serotonin runs wild - unintentionally (Euroanaesthesia 2025) - "Anaesthesia post-operative instructions were written and IV palonosetron administration was documented and handed over to the primary surgical team. However, post-procedurally the patient complained of non-vertiginous giddiness in the general ward and was subsequently administered with IV ondansetron within the half-life duration of palonosetron by the ward team. Increasingly widespread use of psychiatric medications due to increased awareness of mental health globally, prescription of analgesia which can potentially interact with the serotonin pathway.Government funded, training hospitals comprises healthcare professionals of varying seniority and familiarity with less commonly used medication may result in inadvertent errors."

Anesthesia • Psychiatry

Knight Therapeutics Announces Relaunch of ONICIT in Brazil and Mexico (GlobeNewswire) - "Knight Therapeutics Inc...announced today that has assumed full commercial activities and is relaunching ONICIT IV (palonosetron) in Brazil and Mexico, through its affiliates in those countries (United Medical Ltd. and Grupo Biotoscana de Especialidad S.A. de C.V., respectively)....ONICIT solution for injection is approved and marketed in Brazil and Mexico for the prevention of acute nausea and vomiting associated with the initial and repeated cycles of moderately and highly emetogenic chemotherapy for cancer, and for the prevention of delayed nausea and vomiting associated with the initial and repeated cycles of moderately emetogenic chemotherapy for cancer in adults. In addition, ONICIT is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults, for up to 24 hours after surgery."

Relaunch • Chemotherapy-Induced Nausea and Vomiting

Single versus two doses of palonosetron for prevention of chemotherapy-induced nausea and vomiting in children: a double-blind placebo controlled randomized study. (PubMed, J Chemother) - "Children receiving multiple-day (scheduled for ≥3 days) moderately or highly emetogenic chemotherapy (MEC/HEC) were randomized to receive either a single (day 1) or two doses (days 1 and 4) of intravenous palonosetron, in addition to the standard antiemetic prophylaxis. On univariate analysis, younger patient (<10 years), those with solid tumours, did not receive dexamethasone that had significantly higher odds for breakthrough vomiting in Group A. None of these factors retained significance in multivariate logistic regression analysis. Additional intravenous dose of palonosetron on day 4 is effective in controlling CIV during acute phase in children receiving multiple-day MEC/HEC."

CINV • Journal • Chemotherapy-Induced Nausea and Vomiting • Oncology • Pediatrics • Solid Tumor

The efficacy and safety of mirtazapine vs olanzapine in preventing chemotherapy induced nausea and vomiting in combination with the triplet regimen in patients receiving highly emetogenic chemotherapy: An open label, prospective, randomized control study (ESMO Asia 2024) - "Proportion of patients with nausea, vomiting and need of rescue medication during acute, delayed and overall period in both the study groups will be analyzed. Table: 593TiP Treatment arms ARM Drug Days ARM A (FDP-M) INJ FOSAPREPITANT 150mg IV Day1 INJ DEXAMETHASONE 8-12mg IV followed by Day1 TAB DEXAMETHASONE 4mg BD Day 1-4 INJ PALONOSETRON 0.25mg IV Day 1 TAB MIRTAZAPINE 15mg OD Day 1-4 ARM B (FDP-O) INJ FOSAPREPITANT 150mg IV Day1 INJ DEXAMETHASONE 8-12mg IV followed by Day1 TAB DEXAMETHASONE 4mg BD Day 1-4 INJ PALONOSETRON 0.25mg IV Day 1 TAB OLANZAPINE 5mg OD Day 1-4 ."

CINV • Clinical • Combination therapy • Chemotherapy-Induced Nausea and Vomiting • Oncology

A Comparative Study on the Efficacy of Intravenous Palonosetron Versus a Combination of Ondansetron and Dexamethasone as Prophylaxis for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgeries. (PubMed, Cureus) - "Both palonosetron and ondansetron with dexamethasone prove to be comparably effective in preventing PONV in laparoscopic surgeries and achieving a complete response for a longer period, thus requiring fewer rescue medications with no adverse reaction."

Journal • Surgery • Anesthesia

Effect of intravenous palonosetron on hypotension induced by spinal anesthesia for cesarean section: A randomized controlled trial. (PubMed, PLoS One) - "Prophylactic administration of palonosetron did not demonstrate a superior effect over ondansetron in mitigating hemodynamic changes or reducing phenylephrine requirements in patients undergoing spinal anesthesia with bupivacaine and fentanyl for cesarean section."

Clinical • Journal • Anesthesia • Cardiovascular • Hypotension

Effect of Selective 5-Hydroxytryptamine-3 Receptor and Neurokinin-1 Receptor Antagonists on Hemodynamic Changes and Arrhythmogenic Potential in Patients Receiving Chemotherapy: A Retrospective, Observational Study. (PubMed, J Clin Med) - "Patients were grouped by anti-emetic medication: intravenous granisetron (Group G), oral aprepitant plus IV granisetron (Group AG), IV palonosetron (Group P), and oral aprepitant plus IV palonosetron (Group AP). Hypotension was more frequent at 30 min post-medication in granisetron or aprepitant recipients. Considering no hypotension occurred when using palonosetron alone, this treatment was deemed safer."

Journal • Observational data • Retrospective data • Atrial Fibrillation • Cardiovascular • Hypotension

NCCN has published updates to the following NCCN Harmonized Guidelines for Sub-Saharan Africa: Antiemesis, Version 2.2023 (NCCN)

NCCN guideline • Chemotherapy-Induced Nausea and Vomiting

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P3 | N=72 | Recruiting | Sponsor: University of Colorado, Denver | Phase classification: P=N/A ➔ P3 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Phase classification • Trial completion date • Trial primary completion date • Renal Disease

A221602: Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy (clinicaltrials.gov) - P3 | N=690 | Completed | Sponsor: Alliance for Clinical Trials in Oncology | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ May 2023

Trial completion • Trial completion date • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

PHASE 3 EFFICACY AND SAFETY STUDY OF PALONOSETRON IV INFUSION VERSUS IV BOLUS FOR CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) PROPHYLAXIS FOLLOWING HIGHLY EMETOGENIC CHEMOTHERAPY (HEC) (MASCC-ISOO 2017) - P3; "...Currently administered as a 30-sec IV bolus, palonosetron is the preferred 5-HT3RA for MEC in ASCO and NCCN antiemetic guidelines, and in MASCC/ESMO guidelines for anthracycline-cyclophosphamide (AC) regimens when a neurokinin-1 (NK1)–RA is not available. This study was conducted in the context of developing the IV formulation for the netupitant (NK1RA) and palonosetron fixed combination (NEPA), currently available as an oral formulation...Phase 3, multinational, randomized (1:1) double-blind study in 440 chemotherapy-naive patients with solid tumors (NCT02557035) comparing efficacy/safety of 0.25-mg palonosetron 30-min IV infusion vs 30-sec IV bolus, 30 min before HEC (excluding AC), along with oral dexamethasone (20 mg [day 1]; 8 mg twice-daily [days 2–4])...Palonosetron IV infusion was non-inferior to IV bolus in acute CINV prevention after HEC. Safety profiles were similar."

Clinical • Head-to-Head • P3 data • Biosimilar • Oncology

Efficacy of intravenous (IV) NEPA, a fixed NK1/5-HT3 receptor antagonist (RA) combination, for prevention of CINV following cisplatin- and anthracycline cyclophosphamide (AC)-based chemotherapy (CT) (ESMO 2019) - P3b; "An IV formulation of NEPA (fixed combination of the NK 1 RA, fosnetupitant and 5-HT 3 RA, palonosetron) was recently approved in the US and is under review in Europe...Data was also reviewed from 9 phase III cisplatin and AC studies with other NK 1 RA (aprepitant [APR], fosaprepitant [FOS], rolapitant [ROL]) regimens... Both IV and oral formulations of NEPA along with DEX represent highly effective guideline-compliant single-dose antiemetics. Clinical trial identification: NCT03403712. Legal entity responsible for the study: Helsinn Healthcare."

CINV • Clinical • Oncology • Solid Tumor

Aprepitant, palonosetron and dexamethasone proved effective to prevent chemotherapy-related nausea and vomiting in lung cancer (ELCC 2018) - P=N/A; "The percentage of patients, who received rescue antiemetic medication, with metoclopramide included, was set as the primary endpoint. The combination antiemetic therapy was effective and well-tolerated in patients with locally advanced or metastatic LC receiving 1-day full dose cisplatin-based combination chemotherapy."

Lung Cancer

[VIRTUAL] Analysis of Quality-of-Life (QoL) in Patients Receiving NEPA for Prevention of Chemotherapy-Induced Nausea (CINV) and Vomiting (ASH 2020) - "For pts receiving highly emetogenic chemotherapy (HEC), which includes those on anthracycline-cyclophosphamide (AC)-based regimens, a triple combination of a neurokinin-1 receptor antagonist (NK1 RA), a 5-hydroxytryptamine-3 (5-HT3) RA and dexamethasone is recommended by the NCCN and MASCC/ESMO...It is composed of an NK1 RA, netupitant (300 mg) and a 5-HT3 RA, palonosetron (0.50 mg); thus, it acts by blocking two main emetic pathways in a single dose and eases compliance to guidelines...More than half of the pts (1230, 56%) received anthracycline/cyclophosphamide-(AC), 19% carboplatin-, 8% cisplatin-, 7% oxaliplatin- and 9% other CTs...NEPA had beneficial effects on the quality of life and was highly effective in the acute and delayed phase of HEC and MEC. NEPA antiemetic effectiveness was rated highly both by patients and physicians."

CINV • Clinical • HEOR • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Insomnia • Oncology • Sleep Disorder

Phase 3 safety evaluation of an intravenous formulation of NEPA, a novel fixed antiemetic combination of fosnetupitant and palonosetron (ESMO 2017) - P3; "...A single oral NEPA capsule plus dexamethasone (DEX) given prior to AC and non-AC highly emetogenic chemotherapy (HEC) showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) over PALO plus DEX for 5 days post-chemotherapy; the safety of NEPA was also well-established in the Phase 2/3 clinical program in 1442 NEPA-treated patients...Cisplatin was the most frequent HEC (96% of patients) and lung cancer was most common (55% of patients)...Intravenous NEPA was shown to be safe and well-tolerated with a similar safety profile to oral NEPA in patients with various solid tumors receiving HEC."

Clinical • P3 data • Lung Cancer

Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC (clinicaltrials.gov) - P3 | N=328 | Recruiting | Sponsor: Xiamen LP Pharmaceutical Co., Ltd | Trial completion date: Dec 2022 ➔ Nov 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting • Oncology

Ocular Administration of Palonosetron in the Prevention of Cisplatin-Induced Nausea and Vomiting. (PubMed, J Pharmacol Exp Ther) - "We compared ocular administration of palonosetron to non-active vehicle eye drops and to intravenous palonosetron in the prevention of cisplatin-induced nausea and vomiting in beagle dogs. The achieved palonosetron blood concentrations prevented cisplatin-induced nausea and vomiting in beagle dogs. Palonosetron eye drops might provide an easy and quick method for administering palonosetron when parenteral administration is desired and intravenous administration is not feasible."

Journal • Chemotherapy-Induced Nausea and Vomiting • Oncology

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P=N/A | N=72 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Renal Disease

Management of Chemotherapy Induced Nausea and Vomiting (CINV) (GBCC 2022) - "Fosnet-upitant (FN) is a phosphorylated prodrug of netupitant, which has high binding affinity and selectivity for the neurokinin 1 (NK1) receptor. 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 • Chemotherapy-Induced Nausea and Vomiting • Dermatology • Pain • Urticaria

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

Knight Therapeutics and Helsinn Healthcare SA Enter into Exclusive License, Distribution, and Supply Agreement for Akynzeo and Aloxi (GlobeNewswire) - "Knight Therapeutics Inc....and Helsinn Healthcare SA...announced that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI® oral/IV (palonosetron) in Canada....Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees."

Licensing / partnership • Oncology