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Press release / Mar 17, 2015

Novartis receives EU approval for Jakavi® in polycythemia vera, first targeted therapy approved for patients with this rare blood cancer

Jakavi® (ruxolitinib) approved by the European Commission for adult patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea PV is a rare blood cancer associated with…
Press release / Jun 03, 2021

Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera

At final analysis, study showed clinically relevant improvement in median overall survival with a difference of 11.7 months between arms (Hazard ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30,…
Press release / Dec 13, 2022

Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer

EC approval based on results from pivotal Phase III VISION trial, in which Pluvicto® plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free…
Press release / Jan 24, 2018

Novartis exclusively licenses first ophthalmology gene therapy in all markets outside the US, a milestone for patients with rare inherited vision loss

Novartis enters into a licensing and supply agreement to develop, register and commercialize investigational gene therapy voretigene neparvovec outside the US; Spark Therapeutics retains US rights…
Ad hoc release / Mar 23, 2022

Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer

Ad hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive…
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 / Nov 05, 2018

Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms

26 potential blockbusters in confirmatory development[1]. 13 projects in clinical development across Cell, Gene & Radioligand therapies. 60 major submissions[2] planned from 2019 to 2021…
Press release / Jul 24, 2015

Novartis combination therapy Tafinlar® and Mekinist® achieves important EU and US regulatory milestones

CHMP positive opinion for EU approval of Tafinlar and Mekinist combination in BRAF V600 mutation-positive melanoma, the most aggressive type of skin cancer FDA grants priority review for…
Press release / Dec 08, 2018

Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease

Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine…
Press release / Feb 19, 2016

Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML)

PKC412 (midostaurin) significantly improved overall survival of adult patients eligible to receive standard induction and consolidation chemotherapy AML has the lowest survival rate of all adult…

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