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Press release / Oct 23, 2017

Novartis combination adjuvant therapy Tafinlar® + Mekinist® receives FDA Breakthrough Therapy Designation for stage III BRAF V600 mutation-positive melanoma patients

Breakthrough Therapy Designation based on Phase III study showing the three-year relapse-free survival (RFS) rate for patients treated with the combination was 58%, compared to 39% with placebo1…
Press release / Nov 29, 2017

Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab (AMG334) in migraine prevention

Patients with episodic migraine taking erenumab reported significant and meaningful benefits over six months, with reduced migraine days and acute medication use Fifty percent of patients…
Ad hoc release / Oct 02, 2023

Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria…
Ad hoc release / Oct 30, 2023

Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Phase III ALIGN study met its primary endpoint, demonstrating superiority of atrasentan vs. placebo in proteinuria reduction at 36-week interim analysis1;…
Press release / Dec 06, 2015

Novartis drug PKC412 (midostaurin) improves overall survival by 23% in global Phase III study of AML patients with FLT3 mutations

Study in partnership with the Alliance for Clinical Trials in Oncology is the first large controlled trial to show overall survival benefit in FLT3-mutated AML AML is the most common acute…
Press release / Aug 17, 2021

Novartis announces positive results from Phase III trials of Beovu® in diabetic macular edema, including dosing intervals up to 16 weeks

Results from year two of the pivotal Phase III KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one1,2 In key fluid-related…
Ad hoc release / Mar 23, 2021

Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer

Phase III VISION study with 177Lu-PSMA-617 met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive…
Press release / May 29, 2020

Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery

More than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1 Study conclusions are drawn from the largest dataset and…
Press release / Sep 19, 2020

Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma

Based on unprecedented progression-free survival results, Tafinlar (dabrafenib) + Mekinist (trametinib) confirmed as standard-of-care, targeted therapy for advanced BRAF-mutated melanoma1-4 …
Press release / May 01, 2021

Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept

In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints of non-inferiority in change in best corrected visual acuity from baseline versus aflibercept 2 mg at year one in diabetic…

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