Novartis update following WHO Solidarity trial announcement

On May 25, 2020 the World Health Organization (WHO) announced a temporary pause of the hydroxychloroquine (HCQ) arm within the Solidarity trial. The decision was based, in part, on publication in The Lancet 1 of an analysis of hydroxycholoroquine and chloroquine and their effects on hospitalized COVID-19 patients. Novartis has taken note of this retrospective, observational study of existing multinational hospital registry data and our medical teams are evaluating the findings reported in the publication.

The medical evidence on hydroxychloroquine in COVID-19 …

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Novartis at ASCO

We are boldly reimagining cancer and blood disorders.

Novartis ASCO20 Virtual Portal

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Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease

  • New MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program
     
  • Subgroup analysis shows Kisqali plus endocrine therapy extended life compared to endocrine therapy for patients with liver metastases – showing ~47% and 37% reduction in the risk of death in M7 and M3, respectively1
     
  • Visceral metastases, especially liver or brain metastases, generally signify a poor prognosis and more aggressive disease for patients2,3 …
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Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS)

  • Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1
     
  • A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively1
     
  • Regulatory action for ofatumumab in RMS in the US is expected in June 2020
     
  • If approved, ofatumumab has the potential to become a first-choice treatment for RMS …
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Novartis study reveals that migraine support in the workspace can significantly decrease the impact of the disease on affected employees

  • The patients that completed the Migraine Care pilot program reported over 50% reduction in migraine disability and a significant improvement in their patient activation measure after six months
     
  • Participants received six monthly sessions of individualized telecoaching comprised of educational modules and action plans from a specialized nurse by phone and through a specially developed module on the Migraine Buddy smartphone application
     
  • The program was provided as a complimentary service to all Swiss-based …
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AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

  • Zolgensma® (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy (SMA) and a clinical diagnosis of SMA Type 1; or SMA patients with up to three copies of the SMN2 gene
     
  • Zolgensma has demonstrated significant and clinically meaningful therapeutic benefit in pre-symptomatic and symptomatic SMA, including prolonged event-free survival and achievement of motor milestones unseen in natural history of the disease and to date, sustained for 5 years post-dosing  
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Novartis data at ASCO and EHA showcase bold approaches to reimagine cancer and blood disorders through multiple therapeutic platforms

  • New Kisqali® (ribociclib)* overall survival subgroup analysis in HR+/HER2- advanced breast cancer (ABC) and additional Piqray® (alpelisib) data in patients in HR+/HER2- ABC patients with a PIK3CA mutation
  • Results from five-year adjuvant treatment study among BRAF+ melanoma patients taking Tafinlar®+Mekinist® (dabrafenib+trametinib) after surgical removal of their cancer
     
  • New data in non-small cell lung cancer, including efficacy and safety data for …
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Moving from speculation to science during a pandemic

It was the early ’90s, and a medical student in Caracas, Venezuela, named Florencia Segal was attending rounds at a state hospital as part of her training. She was struck by the number of patients with opportunistic infections due to acquired immunodeficiency syndrome (AIDS) and the grim picture that they faced. There were no effective therapies available to treat the roots of their disease.

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It takes an R&D village to fight a pandemic

Gervais Tougas never thought he’d have to face this again. In 2003, while serving as a division head in one of McMaster University’s teaching hospitals, a SARS outbreak in nearby Toronto, Canada tossed his organization into uncharted waters. Like its coronavirus cousin, COVID-19, SARS posed an imminent, deadly threat to public health. To ensure the safety of the hospital and the surrounding community, the entire organization had to pivot from its usual medical practice and prepare itself to weather the outbreak.

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Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14


 

  • Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)1 
  • ~4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year in the US and may face poor prognosis due to presence of the mutation2-3
     
  • Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated METex14 patients, …
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