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Press release / Sep 03, 2016

Novartis' Ultibro® Breezhaler® consistently more effective than Seretide®* in reducing COPD flare-ups across different patient groups

Ultibro® Breezhaler® reduced rate of all COPD exacerbations across different patient sub-groups vs Seretide® in new analyses from FLAME study Analyses show that Ultibro Breezhaler lowered…
Press release / May 26, 2017

Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC)

In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival (PFS) was 16.6 months, compared to 8.1 months with chemotherapy[1] The overall intracranial response rate…
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]…
Press release / May 18, 2017

Novartis data at ASCO, ICML and EHA meetings demonstrate meaningful advancements in cancer care

Updated analyses from the Kisqali® pivotal Phase III MONALEESA-2 trial in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer to be…
Press release / Dec 16, 2016

Novartis drug Votubia® recommended by CHMP for EU approval to treat refractory partial-onset seizures in patients with TSC

If approved, Votubia would be the first adjunctive treatment specifically for refractory seizures in children and adults with tuberous sclerosis complex (TSC)[1] Seizures are the most…
Ad hoc release / Nov 10, 2017

Novartis brolucizumab (RTH258) demonstrates superiority versus aflibercept in key secondary endpoint measures of disease activity in nAMD, a leading cause of blindness

Brolucizumab, the first and only anti-VEGF to maintain a majority of patients on a 12-week treatment schedule immediately following loading phase in Phase III trials, met primary endpoint of non-…
Press release / Nov 06, 2017

Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA* to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Application follows sBLA submission to the FDA for r/r DLBCL which marked second US application for first-ever FDA approved CAR-T therapy Building on the US r/r B-cell ALL experience, Novartis…
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 / Jun 03, 2018

Third Novartis Phase III trial shows Kisqali® combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer

Kisqali plus fulvestrant demonstrated superior efficacy, with a median PFS of 20.5 months vs. 12.8 months for fulvestrant alone, among overall study population of first- and second-line…
Press release / Jun 26, 2020

Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

If approved, Xolair® (omalizumab) will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-…

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