Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

  • Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (IT) formulation in older patients with SMA to further support registration


Basel, September 23, 2020 – Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older …

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Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale

  • Kisqali is the only CDK4/6 inhibitor, in combination with endocrine therapy, to achieve a perfect 5 out of 5 score – confirming substantial benefit for premenopausal women with HR+/HER2- advanced breast cancer (aBC), based on significant overall survival (OS) benefit and improved quality of life, in the MONALEESA-7 study1
     
  • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 for first-line postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained quality of life observed in MONALEESA-32 …
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Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation

  • In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone1
     
  • 14+ months OS improvement was achieved in patients with lung or liver metastases, which are observed in 41% of postmenopausal women with HR+ aBC, and considered more aggressive and challenging to treat1-3 
     
  • Data add to growing body of evidence for …
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Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma

  • Based on unprecedented progression-free survival results, Tafinlar (dabrafenib) + Mekinist (trametinib) confirmed as standard-of-care, targeted therapy for advanced BRAF-mutated melanoma1-4
     
  • Data show positive durable responses and progression-free survival benefit for patients treated with Tafinlar + Mekinist in the comparator arm of the COMBI-i clinical trial despite the study not meeting the primary endpoint for the investigational triplet therapy
     
  • Spartalizumab …
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Novartis at ESMO

Novartis 2020 ESMO Annual Meeting Virtual Portal

Novartis at ESMO image

We are boldly reimagining cancer and blood disorders.

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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 treatment with standard-of-care targeted therapy Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo1
     
  • Updated data show Tafinlar + Mekinist improved distant metastasis-free survival, a secondary endpoint1

             
Basel, September 16 …

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Committed to increasing access

Patient and healthcare worker in Vietnam

Novartis reinforces its commitment to environmental, social and governance (ESG) principles and the …

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Novartis reinforces commitment to patient access, pricing a EUR 1.85 billion sustainability-linked bond

  • First healthcare industry sustainability-linked bond (SLB) further embeds Environmental Social Governance (ESG) targets into the core of Novartis business operations

  • SLB linked to 2025 Patient Access Targets to increase patients reached in low- and middle-income countries (LMICs) with strategic innovative therapies by 200% and the Novartis Flagship Programs by 50%

Basel, September 16, 2020 — Novartis today announced the pricing of a EUR 1.85 billion sustainability-linked bond (SLB), reinforcing its commitment to ESG …

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Bringing science and medicine together to help patients with cancer

One of the biggest game-changing advancements in cancer care came about 20 years ago when researchers learned that they could create medicines that selectively jam up cancer’s growth machinery without damaging the rest of the body. Today these medicines, called targeted therapies, are available for treating many forms of cancer.

Targeted therapies took center stage when Alice Shaw started her career as a physician-scientist caring for patients with lung cancer. Now, as Global Head of Translational Clinical Oncology at the Novartis Institutes for BioMedical Research (NIBR), Shaw aims …

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European Medicines Agency (EMA) approves safety label update for Novartis Beovu®

  • Novartis worked with the EMA to update the Beovu® (brolucizumab) label to guide physicians in their treatment of wet AMD  
     
  • The update includes the additional characterization of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation1
     
  • Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of these adverse events
     
  • …
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