A blood cancer patient’s long road to diagnosis

Myeloproliferative neoplasms (MPNs) are a group of rare blood cancers, including myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET), that affect blood cell production in the bone marrow. These blood cancers may result in debilitating symptoms that can burden daily life. Unfortunately, patients often struggle to have their needs met when confronting their illness. The good news is, people all over the world living with MPNs, their caregivers and clinicians are working together to understand the unique physical, emotional and economic challenges that the MPN …

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Novartis announces discontinuation of CIRRUS-1 study of CFZ533 (iscalimab) in kidney transplant patients

Novartis today announced that following an interim analysis of data from the CIRRUS-1 study, a decision has been taken to discontinue the trial. 

  • The analysis indicated that CFZ533 (iscalimab)-based treatment is less efficacious compared to tacrolimus-based treatment in the prevention of organ rejection in patients receiving a kidney transplant. Both CFZ533 and tacrolimus were used in combination with other immunosuppressive therapies (induction therapy, mycophenolate and corticosteroids).
  • Study of CFZ533 in liver transplant continues, as do studies exploring CFZ533 as a …
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Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions

  • Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair® Breezhaler® (IND/GLY/MF*) and Atectura® Breezhaler® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively1,2
  • Data from post hoc analyses of the Phase III PLATINUM program (including IRIDIUM and ARGON studies) further establish efficacy of Enerzair …
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Novartis receives FDA fast track designation for LNA043 in osteoarthritis of the knee

Novartis today announced that the US Food and Drug Administration (FDA) has granted fast track designation for LNA043 for the treatment for osteoarthritis of the knee. Fast track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs.1 LNA043 is being developed as a potential first in class disease modifying treatment for osteoarthritis (OA). 

OA is a chronic degenerative disease characterized by a progressive loss of cartilage, leading to pain, loss of joint function and disability. It affects …

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World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio® ▼(inclisiran)

  • Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England1
  • Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a 6-monthly maintenance dose‡, in the community setting
  • Long-term elevated LDL cholesterol (LDL-C) …
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Novartis sabatolimab receives orphan drug designation from the European Commission for myelodysplastic syndromes

Novartis announced today that the European Commission (EC) has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes (MDS), based on clinical data showing a high rate of responses in patients with high-risk MDS who were treated with sabatolimab in combination with hypomethylating agents (HMAs). The decision follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA)1.

  • MDS are a group of rare and often underdiagnosed blood cancers characterized by two major …
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Novartis Leqvio®* (inclisiran) analyses show effective and sustained LDL-C reduction in two sub-populations of patients with ASCVD

  • Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly** Leqvio® (inclisiran) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) with established cerebrovascular disease (CeVD)1 and polyvascular disease (PVD)2
  • Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials1 …
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Novartis presents important overall survival and quality-of-life results across solid tumor portfolio, among other key data at ESMO

  • New Kisqali® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2− advanced breast cancer patients in the first-line setting

  • Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer

  • Data supporting upcoming regulatory filings for tislelizumab in people with squamous and non-squamous non-small cell …
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FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukemia (CML)

Novartis today announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application (NDA) for asciminib (ABL001) in chronic myeloid leukemia (CML), following its submission under the FDA’s Real-Time Oncology Review (RTOR) program. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1. This designation could shorten the FDA review period to eight months compared to the 12 months …

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Novartis provides update on BELINDA study investigating Kymriah® as second-line treatment in aggressive B-cell non-Hodgkin lymphoma

  • Phase III BELINDA study did not meet primary endpoint of event-free survival for patients with aggressive B-cell non-Hodgkin lymphoma who had primary refractory disease or who relapsed within 12 months of first-line treatment
  • Novartis CAR-T innovation continues to accelerate development of next-generation platform with improved CAR-T cellular characteristics, high speed, lower cost of goods sold (COGS) and advancement of clinical research into new indications and targets; early clinical data anticipated at upcoming medical meeting
  • …
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