- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka
Clinical, P3 data, Journal, CINV: A Randomized Phase 3 Study Evaluating the Efficacy of Single-dose NEPA, a Fixed Antiemetic Combination of Netupitant and Palonosetron, Versus an Aprepitant Regimen for Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC). (Pubmed Central) - Apr 3, 2019 ...NEPA, a fixed combination of a highly selective NK1 receptor antagonist, netupitant (300 mg), and the pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), has shown superior CINV prevention compared with PALO in cisplatin and anthracycline/cyclophosphamide-based settings...All patients also received oral dexamethasone (DEX) on days 1-4...NEPA was well tolerated with a similar safety profile to APR/GRAN. In this first study comparing NK1RA regimens and DEX, NEPA administered only on day 1 was non-inferior to a 3-day oral APR/GRAN regimen in preventing CINV associated with HEC.
- |||||||||| cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
Trial primary completion date: AKY15-HK-301_NEPA Study (clinicaltrials.gov) - Feb 22, 2019 P2, N=60, Recruiting, In this first study comparing NK1RA regimens and DEX, NEPA administered only on day 1 was non-inferior to a 3-day oral APR/GRAN regimen in preventing CINV associated with HEC. Trial primary completion date: Dec 2018 --> Dec 2019
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica
New P4 trial, HEOR: Comparative Effectiveness of AKYNZEO (clinicaltrials.gov) - Feb 6, 2019 P4, N=426, Recruiting,
- |||||||||| cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
Enrollment open, Trial initiation date: AKY15-HK-301_NEPA Study (clinicaltrials.gov) - Mar 2, 2018 P2, N=60, Recruiting, Initiation date: Feb 2018 --> Mar 2018 Not yet recruiting --> Recruiting | Initiation date: Mar 2018 --> Feb 2018
- |||||||||| cyclophosphamide / Generic mfg., doxorubicin hydrochloride / Generic mfg.
New P2 trial: AKY15-HK-301_NEPA Study (clinicaltrials.gov) - Dec 29, 2017 P2, N=60, Not yet recruiting,
- |||||||||| Journal: Prevention of chemotherapy-induced nausea: the role of neurokinin-1 (NK1) receptor antagonists. (Pubmed Central) - Oct 20, 2017
Aprepitant has not shown consistent superiority over a two-drug (ondansetron-dexamethasone) combination in nausea control after cisplatin- or anthracycline-cyclophosphamide (AC)-based highly emetogenic chemotherapy (HEC)...The potential impact of the new NK1RAs rolapitant and netupitant (oral fixed combination with palonosetron, as NEPA) in CIN prophylaxis is discussed...Recently, NK1RAs have been challenged by olanzapine, with olanzapine showing superior efficacy in nausea prevention after HEC. Fixed antiemetic combinations (such as NEPA) or new antiemetics with a long half-life that may be given once per chemotherapy cycle (rolapitant or NEPA) may improve patient compliance with antiemetic treatment.
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Aloxi (palonosetron oral) / Helsinn, Otsuka, Roche, Eisai
Journal: NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron. (Pubmed Central) - Oct 13, 2017 Fixed antiemetic combinations (such as NEPA) or new antiemetics with a long half-life that may be given once per chemotherapy cycle (rolapitant or NEPA) may improve patient compliance with antiemetic treatment. NEPA, a convenient, guideline-consistent, fixed antiemetic combination is effective and safe over multiple cycles of chemotherapy.
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Aloxi (palonosetron oral) / Helsinn, Otsuka, Roche, Eisai
Review, Journal: NEPA, a new fixed combination of netupitant and palonosetron, is a cost-effective intervention for the prevention of chemotherapy-induced nausea and vomiting in the UK. (Pubmed Central) - Apr 12, 2017 Not yet recruiting --> Recruiting Despite study limitations (study setting, time horizon, utility measure), the results suggest NEPA is cost effective for preventing CINV associated with HEC and MEC in the UK.
- |||||||||| Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Mundipharma, Immedica, Akynzeo IV (fosnetupitant/palonosetron) / Helsinn
Trial completion: A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting (clinicaltrials.gov) - Sep 8, 2016 P3, N=405, Completed, Despite study limitations (study setting, time horizon, utility measure), the results suggest NEPA is cost effective for preventing CINV associated with HEC and MEC in the UK. Recruiting --> Completed
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