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June 29, 2017 01:15 ET | Source: Novartis Pharma AG

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

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival (PFS) compared to SOC chemotherapy with maintenance[1] Zykadia benefit was also seen in...
June 27, 2017 01:15 ET | Source: Novartis Pharma AG

Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases

European Commission approves Sandoz Erelzi® to treat immunological diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis Approval of Erelzi provides more treatment options...
June 23, 2017 12:00 ET | Source: Novartis Pharma AG

NEJM publishes full analysis of Rydapt® (midostaurin) Phase III RATIFY trial in newly diagnosed FLT3-mutated acute myeloid leukemia (AML)

Significant overall survival benefit observed for FLT3+ AML patients consistent across FLT3 mutation subgroups, including ITD and TKD Detailed data show Rydapt plus standard chemotherapy improved...
June 23, 2017 04:40 ET | Source: Novartis Pharma AG

Novartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor

CHMP opinion based on pivotal Phase III trial that showed Kisqali plus letrozole reduced risk of disease progression or death by 44% over letrozole alone among postmenopausal women with HR+/HER2-...
June 23, 2017 02:40 ET | Source: Novartis Pharma AG

Novartis data shows half of eligible Ph+ CML-CP patients remain in Treatment-free Remission nearly two years after stopping Tasigna®

New 96-week data support durability and safety of Treatment-free Remission (TFR) in Ph+ CML-CP patients who stop taking Tasigna [1,2] More than 90% of Ph+ CML-CP patients in ENESTfreedom and...
June 23, 2017 02:35 ET | Source: Novartis Pharma AG

Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL

83% of patients achieved complete remission (CR) or CR with incomplete blood count recovery within 3 months of treatment with CTL019; consistent with interim ELIANA data Data evaluating 63...
June 22, 2017 17:42 ET | Source: Novartis Pharma AG

Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)

Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic NSCLC More than 60% of treatment-naïve and previously treated patients with BRAF...
June 22, 2017 01:15 ET | Source: Novartis Pharma AG

Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack

Phase III CANTOS study met the primary endpoint, a composite of heart attack, stroke and cardiovascular death, showing that ACZ885 (canakinumab) in combination with standard of care therapy...
June 21, 2017 01:15 ET | Source: Novartis Pharma AG

Novartis achieves important regulatory milestone for AMG 334 (erenumab) in migraine prevention with EMA filing acceptance

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance Filing is supported by a comprehensive clinical...
June 20, 2017 01:15 ET | Source: Novartis Pharma AG

Novartis RTH258 (brolucizumab) demonstrates robust visual gains in nAMD patients with a majority on a 12-week injection interval

RTH258 achieved the primary efficacy endpoint of non-inferiority to aflibercept in mean change in BCVA from baseline to week 48[1],[2] in two head-to-head pivotal Phase III studies[3],[4] 57%...