Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka 
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  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Akynzeo IV (fosnetupitant/palonosetron) / Helsinn
    An Indian real-world experience of intravenous fosnetupitant-palonosetron (IV NEPA) in preventing delayed and extended delayed CINV. (Hall A; Poster Bd #: 199) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_2820;    
    Cisplatin-Paclitaxel (19.10%) and Carboplatin-Paclitaxel (35.39%) were the most common HEC and MEC regimens respectively... IV NEPA demonstrated high efficacy and good tolerability in a real world Indian setting, exhibiting response rates of >92% in both delayed and extended delayed phases in patients receiving HEC/MEC regimens.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Enrollment closed, Trial primary completion date:  Oral Akynzeo (clinicaltrials.gov) -  Apr 18, 2024   
    P4,  N=414, Active, not recruiting, 
    Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases. Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Jul 2024
  • ||||||||||  cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
    Enrollment closed:  AKY15-HK-301_NEPA Study (clinicaltrials.gov) -  Nov 27, 2023   
    P2,  N=55, Active, not recruiting, 
    Trial completion date: Jun 2025 --> Jun 2024 | Trial primary completion date: Jun 2025 --> Apr 2024 Recruiting --> Active, not recruiting
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Trial completion date, Trial primary completion date:  Oral Akynzeo (clinicaltrials.gov) -  Nov 9, 2022   
    P4,  N=530, Recruiting, 
    N=1200 --> 1600 | Trial completion date: May 2023 --> Jun 2025 | Trial primary completion date: Dec 2022 --> Jun 2025 Trial completion date: Aug 2023 --> Nov 2024 | Trial primary completion date: Apr 2023 --> Apr 2024
  • ||||||||||  cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
    Trial completion date, Trial primary completion date:  AKY15-HK-301_NEPA Study (clinicaltrials.gov) -  Sep 15, 2022   
    P2,  N=60, Recruiting, 
    Enrollment is open; as of July 7, 141 patients have been randomized. Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2024
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka
    Trial completion date, Trial primary completion date:  Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration (clinicaltrials.gov) -  Jul 15, 2022   
    P2,  N=30, Recruiting, 
    Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2024 Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Trial completion, Trial completion date, Trial primary completion date:  Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer (clinicaltrials.gov) -  Mar 7, 2022   
    P2/3,  N=45, Completed, 
    This could be a potential prophylactic regimen of choice for patients who have a contraindication for Dexamethasone use. Active, not recruiting --> Completed | Trial completion date: Nov 2022 --> Feb 2022 | Trial primary completion date: Nov 2022 --> Feb 2022
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Trial completion date, Trial primary completion date:  Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer (clinicaltrials.gov) -  Jan 11, 2022   
    P2/3,  N=53, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Nov 2022 --> Feb 2022 | Trial primary completion date: Nov 2022 --> Feb 2022 Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2021 --> Nov 2022
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma
    Review, Journal, CINV:  Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting. (Pubmed Central) -  Dec 17, 2021   
    Administered as a single dose, (fos)netupitant/palonosetron (in combination with dexamethasone) is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults...Both the oral and IV formulations of the drug combination are well tolerated. The fixed-dose combination is concordant with guideline recommendations and provides a simple and convenient option for prophylaxis against acute and delayed CINV in patients receiving highly or moderately emetogenic chemotherapy.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Trial completion date, Trial primary completion date:  Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin (clinicaltrials.gov) -  Dec 14, 2021   
    P2/3,  N=80, Recruiting, 
    The fixed-dose combination is concordant with guideline recommendations and provides a simple and convenient option for prophylaxis against acute and delayed CINV in patients receiving highly or moderately emetogenic chemotherapy. Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Avastin (bevacizumab) / Roche, netupitant (Ro 67-3189) / Helsinn, Otsuka
    Clinical, Journal, CINV:  NEPA (netupitant/palonosetron) for the antiemetic prophylaxis of nausea and vomiting induced by chemotherapy (CINV) with Folfirinox and Folfoxiri even during the COVID-19 pandemic: a real-life study. (Pubmed Central) -  Sep 15, 2021   
    NEPA (Akynzeo®), is an oral fixed-dose combination of netupitant [a neurokinin-1 receptor antagonist (NK1RA), 300 mg] and palonosetron [(5-hydroxytryptamine (serotonin or 5HT) type3 receptor antagonist (5HT3RA), 0.5 mg] which has been shown to be effective in preventing CINV...The aim was to evaluate the efficacy and safety of a single oral dose NEPA plus 12 mg of dexamethasone (DEX) in patients treated with Folfoxiri plus Bevacizumab and Folfirinox...This study has shown the therapeutic benefits of NEPA in the management and prophylaxis of CINV events, both in naive patients and patients previously treated with 5HT3-RA and NK1-RA. In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic.
  • ||||||||||  cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
    Enrollment open:  AKY15-HK-301_NEPA Study (clinicaltrials.gov) -  Jul 28, 2021   
    P2,  N=60, Recruiting, 
    In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic. Active, not recruiting --> Recruiting
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma
    [VIRTUAL] AVOIDING ACUTE CARE AND UNPLANNED HYDRATIONS FROM CHEMOTHERAPYINDUCED NAUSEA AND VOMITING (CINV) IN REAL-WORLD PRACTICE () -  Apr 11, 2021 - Abstract #AMCP2021AMCP_189;    
    Among diverse oncology practices, patients receiving NEPA-based prophylaxis for HEC/MEC had half the risk of CINV-related acute care and unplanned hydrations seen for other triple prophylaxis regimens. This significant difference, likely to translate to better quality and cost of care, may be attributable to NEPA’s previously demonstrated benefit in limiting CINV duration.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Enrollment closed:  Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects (clinicaltrials.gov) -  Apr 1, 2021   
    P1,  N=44, Active, not recruiting, 
    This significant difference, likely to translate to better quality and cost of care, may be attributable to NEPA’s previously demonstrated benefit in limiting CINV duration. Not yet recruiting --> Active, not recruiting
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    New P4 trial:  Oral Akynzeo (clinicaltrials.gov) -  Mar 25, 2021   
    P4,  N=530, Recruiting, 
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka
    Trial completion date, Trial primary completion date:  Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration (clinicaltrials.gov) -  Mar 3, 2021   
    P2,  N=30, Recruiting, 
    Protracted administration of dexamethasone provided limited additional benefit. Trial completion date: Jan 2021 --> Feb 2022 | Trial primary completion date: Jan 2021 --> Feb 2022
  • ||||||||||  dexamethasone / Generic mfg.
    Journal:  Antiemetics: ASCO Guideline Update. (Pubmed Central) -  Feb 26, 2021   
    There is no clinical evidence to warrant omission of dexamethasone from guideline-compliant prophylactic antiemetic regimens when CPIs are administered to adults in combination with chemotherapy. CPIs administered alone or in combination with another CPI do not require the routine use of a prophylactic antiemetic.Additional information is available at www.asco.org/supportive-care-guidelines.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Akynzeo IV (fosnetupitant/palonosetron) / Helsinn, netupitant (Ro 67-3189) / Helsinn, Otsuka
    Clinical, P3 data, Review, Journal, CINV:  Efficacy of intravenous NEPA, a fixed NK/5-HT receptor antagonist combination, for the prevention of chemotherapy-induced nausea and vomiting (CINV) during cisplatin- and anthracycline cyclophosphamide (AC)-based chemotherapy: A review of phase 3 studies. (Pubmed Central) -  Jan 23, 2021   
    This paper presents an overview of the efficacy of intravenous (IV) NEPA (fixed combination of the NKRA, fosnetupitant, and 5-HTRA, palonosetron) relative to oral NEPA and also to historical data for other NKRA regimens...The overall (0-120 h) complete response (no emesis, no rescue use), no emesis, and no significant nausea rates for IV NEPA were similar to that of oral NEPA and were consistently numerically higher than historical NKRA regimens. As a single-dose prophylactic antiemetic combination given with dexamethasone, IV NEPA is a highly effective and convenient guideline-compliant antiemetic agent which may offer a safety benefit over other IV NKRA regimens due to its lack of associated hypersensitivity and injection-site reactions.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Helios ocular insert (bimatoprost sustained release insert) / AbbVie
    Journal:  Peter F. Merenda (1922-2019). (Pubmed Central) -  Jan 22, 2021   
    Peter Francis Merenda was a remarkable individual who lived an extraordinary life, impacting people far and wide. In his 97-plus years, Peter accomplished much and gave back much to others- his family, friends, colleagues, students, community, country, and internationally.
  • ||||||||||  Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
    Trial primary completion date:  Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer (clinicaltrials.gov) -  Jan 15, 2021   
    P2/3,  N=53, Active, not recruiting, 
    In his 97-plus years, Peter accomplished much and gave back much to others- his family, friends, colleagues, students, community, country, and internationally. Trial primary completion date: Nov 2020 --> Nov 2021