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RYBREVANT™ (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Share this article Share this article HORSHAM, Pa., May 21, 2021 /PRNewswire/  The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANT TM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. 1 RYBREVANT TM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.

WCLC: J&J s bispecific antibody hinders 74% of lung cancers with rare EGFR mutation

Jan 28, 2021 10:45pm Johnson & Johnson is seeking a nod for amivantamab as a second-line treatment for lung cancer patients with a rare EGFR mutation, but the company is already working on moving the candidate into the front-line setting. (Janssen) Johnson & Johnson’s EGFR-MET bispecific antibody is padding its case ahead of a potential FDA nod. The drug shrank tumors in 40% of lung cancer patients with a rare EGFR mutation and curbed tumor growth in nearly three-quarters of patients. The phase 2 data, presented virtually at the World Conference on Lung Cancer (WCLC), come from 81 patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions. The patients’ cancer had spread beyond the lungs or couldn’t be treated with surgery and had gotten worse despite taking platinum chemotherapy.

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