Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study

  • Men who received 177Lu-PSMA-617 plus best standard of care had a 38% reduction in risk of death (median OS benefit of 4 months) and a 60% reduction in the risk of radiographic disease progression or death (median rPFS benefit of 5 months) compared to best standard of care alone1
  • Significant improvement demonstrated in all key secondary endpoints, including time to first symptomatic skeletal event, overall response rate and disease control rate1
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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 infusion1

  • Robust response observed in heavily pretreated patients in critical need of a potentially definitive treatment option1,2

  • No patients in ELARA trial experienced grade 3/4 cytokine release syndrome, the most common side effect associated with CAR-T therapy1

  • Global regulatory …
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Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients

  • MONALEESA-3 median overall survival (OS) results of 53.7 months underscore that Kisqali offers more life to postmenopausal women with HR+/HER2- metastatic breast cancer (MBC) in addition to the OS benefit demonstrated for premenopausal women as shown in MONALEESA-71,2

  • The relative risk reduction of death by 36% in the MONALEESA-3 first-line (1L) postmenopausal population highlights that Kisqali is the only CDK4/6i with proven OS for 1L in combination with fulvestrant1

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Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx® as a potential treatment in a JIA population at EULAR 2021

  • Phase III JUNIPERA study met its primary endpoint, with Cosentyx® (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs. placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA)2

  • JIA has limited treatment options and affects approximately 2 million children worldwide3,4. Subtypes juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA …
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Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis

  • Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo1
  • The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials and is consistent with the established adult psoriasis indication1
  • Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with …
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Novartis Hematology: Relentless Pursuit of a Cure

Scientist in lab

Novartis is deeply committed to transforming the lives of people living with blood cancers and life-threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms, and free from disease – this is our vision for the future.

Reimagining Myeloid Disorders

Novartis – together …

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Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program

  • Beovu (brolucizumab) met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline and superiority on anatomical secondary endpoints at year one versus aflibercept when given every four weeks following the loading phase1
  • In this study evaluating every four week dosing, Beovu was associated with higher rates of IOI including retinal vasculitis and retinal vascular occlusion versus aflibercept1
  • Patient safety is of paramount …
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Two Decades of Pioneering Innovation in CML and Beyond

Scientist checking samples

A Breakthrough for CML and Cancer Treatment

In May 2001 – exactly 20 years ago – Novartis received approval from the US Food and Drug Administration (FDA) for the first targeted therapy for cancer, known as a tyrosine kinase inhibitor (TKI). This was a watershed moment in drug discovery, transforming the treatment landscape for chronic …

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Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19

  • EMPATHY global multi-center Phase 2 – 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalization
  • The study plans to enroll 2100 patients, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3
  • Novartis has been granted an option from Molecular Partners to in-license global rights of ensovibep and MP0423 – DARPin® antiviral therapeutic candidates that are undergoing testing to target SARS-CoV-2 …
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Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes

Novartis today announced that the US Food and Drug Administration (FDA) has granted fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes (MDS). Fast track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs1.

  • MDS, a group of rare and often underdiagnosed blood cancers, is characterized by a dysfunctional immune system and leukemic stem cell proliferation2-4.
  • Despite treatment with HMAs – the last treatment innovation in higher-risk (HR) MDS over …
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