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Press release / Dec 09, 2016

Novartis LEE011 (ribociclib) plus letrozole analyses show superior PFS across broad spectrum of patients in first-line HR+/HER2- advanced breast cancer versus letrozole

MONALEESA-2 analyses demonstrate superior PFS with LEE011 plus letrozole in pre-defined patient subgroups - from de novo to bone, liver and lung metastases - compared to letrozole alone …
Ad hoc release / Jun 29, 2018

Novartis receives positive CHMP opinion for Kymriah® for treating two aggressive blood cancers, marking important medical advance for patients in Europe

First CHMP opinion for a CAR-T cell therapy in two distinct indications - DLBCL in adults and B-cell ALL in children Marketing Authorization Application (MAA) based on landmark global CAR-T…
Press release / Dec 22, 2017

Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label

Inclusion of Treatment-free Remission (TFR) data provides additional and novel option in management of Ph+ CML-CP Deep and sustained molecular response included as key eligibility criteria…
Press release / May 19, 2017

Novartis receives positive CHMP opinion for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC)

Phase III trial, first-line treatment with Zykadia resulted in improved progression-free survival (PFS) over SOC chemotherapy with maintenance, including in patients with brain metastases[1]…
Ad hoc release / Dec 05, 2022

Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer

Ad hoc announcement pursuant to Art. 53 LR Phase III PSMAfore trial with PluvictoTM met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA–positive mCRPC who have been…
Press release / Jul 24, 2015

FDA approves Novartis drug Odomzo® (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer

Approval is based on pivotal Phase II study in which objective response rate (ORR) in patients with laBCC was 58%; responses were durable[1] Basal cell carcinoma, the most common form of skin…
Ad hoc release / Jan 29, 2021

Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis

Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS1CHMP opinion is…
Press release / Apr 24, 2018

AveXis Presents Initial Data from Pivotal U.S. Trial for SMA Type 1 and 24-Month Follow-Up Data from Phase 1 Trial of AVXS-101 in SMA Type 1 at the Annual Meeting of the American Academy of Neurology

– A mean increase in CHOP-INTEND of 17.3 was observed at three months post gene therapy in SMA Type 1 U.S. pivotal trial – – All patients in the therapeutic dose cohort in the Phase 1 trial…
Press release / Dec 09, 2025

Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly doses

Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45% with patients maintaining disease control 2.8 times longer than with placebo plus eltrombopag1,2 62% of patients treated with…
Press release / Jun 02, 2021

Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion1Robust response observed in heavily pretreated patients in…

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