- |||||||||| 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
Observational data, Journal, CINV: An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo (Pubmed Central) - Apr 19, 2024 Adverse events were reported in 3.88% of patients. 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.
- |||||||||| 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
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
New P3 trial, Head-to-Head: NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens (clinicaltrials.gov) - Mar 25, 2024 P3, N=627, Not yet recruiting,
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica, netupitant (Ro 67-3189) / Helsinn, Otsuka
EFFICACY AND SAFETY OF NETUPITANT/PALONOSETRON COMBINATION (NEPA) AND LOW DOSE OF DEXAMETHASONE IN PREVENTING NAUSEA AND VOMITING IN PATIENTS UNDERGOING ALLOGENEIC STEM CELL TRANSPLANTATION (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1406; Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Jul 2024 NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica, netupitant (Ro 67-3189) / Helsinn, Otsuka
EFFICACY AND SAFETY OF NETUPITANT/PALONOSETRON COMBINATION (NEPA) AND LOW DOSE OF DEXAMETHASONE IN PREVENTING NAUSEA AND VOMITING IN PATIENTS UNDERGOING ALLOGENEIC STEM CELL TRANSPLANTATION (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1405; NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile
- |||||||||| 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
Assessing the Benefit of NEPA (Fixed Combination of Netupitant/Palonosetron) for Preventing Chemotherapy-induced Nausea and Vomiting (CINV) in Patients at Increased Emetic Risk Receiving Moderately Emetogenic Chemotherapy (Hall 4) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1066; P4 Background: In patients receiving moderately emetogenic chemotherapy (MEC), antiemetic guidelines lack evidence to recommend an NK 1 receptor antagonist (RA) for all patients; therefore, they endorse a 5-HT 3 RA + dexamethasone (DEX)...A generalized linear model will analyze CR over 3 cycles of MEC with logit link function, binomial distribution, and with study treatment, carboplatin use, and the country as factors...Enrollment is open; as of April 26, 2023, 287 patients have been randomized. In Germany, 96 of 100 patients have been enrolled by five study centres.
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka
Enrollment change, Trial completion date, Trial primary completion date: Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (clinicaltrials.gov) - Feb 9, 2023 P3, N=1600, Recruiting, NEPA and low dose of dexamethasone, administered every other day, show to be very effective in preventing CINV in patients undergoing alloSCT with a good tolerability profile N=1200 --> 1600 | Trial completion date: May 2023 --> Jun 2025 | Trial primary completion date: Dec 2022 --> Jun 2025
- |||||||||| 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, 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, Immedica
New P2 trial: Phase II, open-label, not comparative, multicenter study of multiple doses of NEPA (Netupitant+Palonosetron) in preventing chemotherapy induced nausea and vomiting(CINV) in patient with Non Hodgkin (EUDRACT) - Sep 28, 2021 P2, N=81, Ongoing,
- |||||||||| 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, Immedica
Trial completion: Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects (clinicaltrials.gov) - May 26, 2021 P1, N=44, Completed, Importantly, there were no injection-site or hypersensitivity reactions associated with IV NEPA. Active, not recruiting --> Completed
- |||||||||| 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,
- |||||||||| 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
Clinical, Journal, HEOR, Real-World Evidence, CINV: Real-world evidence of NEPA, netupitant-palonosetron, in chemotherapy-induced nausea and vomiting prevention: effects on quality of life. (Pubmed Central) - Feb 9, 2021 NEPA was well tolerated. NEPA had beneficial effects on the quality of life of a heterogeneous group of cancer patients and was safe and effective in the real-world setting.
- |||||||||| 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
|