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Press release / Feb 24, 2017

Novartis receives positive CHMP opinion for Tafinlar® + Mekinist® in BRAF-positive non-small cell lung cancer (NSCLC) patients

If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation CHMP opinion based on positive data from pivotal study of patients…
Press release / Apr 28, 2017

Novartis receives FDA approval for Rydapt® in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM)

Approval in newly diagnosed FLT3-mutated AML represents the first new treatment in more than 25 years[1],[2] Rydapt treatment regimen in FLT3-mutated AML demonstrated a significant improvement…
Press release / Sep 28, 2015

Patients with aggressive form of melanoma lived for more than two years on average when taking Novartis therapies Tafinlar® + Mekinist®

Phase III data showed median overall survival of 25.6 months in patients with BRAF+ V600E/K metastatic melanoma who received Tafinlar + Mekinist Tafinlar + Mekinist combination also demonstrated…
Press release / Apr 30, 2018

Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma

Tafinlar + Mekinist is the first oral targeted adjuvant combination therapy to demonstrate significant clinical benefit in patients with a BRAF V600 mutation, following complete surgical resection…
Press release / Nov 05, 2019

Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

Ziextenzo™ is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy With approval of Ziextenzo™ , Sandoz is first and only…
Ad hoc release / May 24, 2019

FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer

Piqray (alpelisib, formerly BYL719) plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulvestrant alone…
Press release / Sep 16, 2020

Novartis Tafinlar® + Mekinist® demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM

COMBI-AD is first trial to demonstrate 5-year relapse-free survival with targeted therapy as adjuvant treatment in high-risk patients with stage III BRAF-mutated melanoma1 Adjuvant…
Press release / Nov 13, 2020

New Novartis analyses for investigational inclisiran demonstrate consistently effective and sustained LDL-C reduction at month 17 regardless of age and gender

Pooled data analyses from Phase III ORION-9, -10 and -11 showed that inclisiran consistently reduced low-density lipoprotein cholesterol (LDL-C) by approximately 51% in both male and female…
Press release / Jun 15, 2016

Novartis expands partnership with Medicines for Malaria Venture to develop next-generation antimalarial treatment

Novartis will lead the development of antimalarial compound KAF156 with scientific and financial support from Medicines for Malaria Venture in collaboration with the Bill & Melinda Gates…
Ad hoc release / Jan 08, 2024

Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia

MEDIA & INVESTOR RELEASE Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard-of-care TKIs in Phase III trial for newly diagnosed patients with chronic…

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