Basel, August 15, 2022 — Novartis announced today that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) did not meet its primary endpoint of…

Basel, June 30, 2022 — In early June, Novartis restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy, and Millburn, New Jersey, and resumed delivery of doses to patients in a phased approach, ahead of the expected six-week timeframe. The company has remediated the issues that led to the temporary, voluntary suspension of…

Basel, June 30, 2022 — Today Novartis announced results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status.…

Basel, June 24, 2022 — Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix® (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid…

Basel, June 23, 2022 — Novartis today announced the US Food and Drug Administration (FDA) granted accelerated approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following…

Basel, June 22, 2022 — Novartis announced today that the European Commission (EC) approved Tabrecta® (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy…

Basel, June 12, 2022 — Novartis today announced long-term results from the ELIANA pivotal clinical trial of Kymriah® (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years. For…

Basel, June 7, 2022 — Novartis today announced longer-term follow-up data from the Phase III ASCEMBL trial for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), presented at the 2022 American Society of Clinical Oncology (ASCO…

Basel, June 6, 2022 — Novartis today announced Tafinlar® (dabrafenib) + Mekinist® (trametinib) significantly improved efficacy in patients ages 1 to 17 years old with BRAF V600 pediatric low-grade glioma (pLGG) requiring first systemic treatment compared to chemotherapy, the current standard-of-care for these patients1. In this study, patients…

Basel, June 3, 2022 — Novartis today announced results of an exploratory retrospective biomarker analysis finding that different genetic mutation profiles in tumors harboring PIK3CA mutation did not affect treatment benefit with Piqray® (alpelisib) plus fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor-…