RSS FLASCO

  • FDA approves Regeneron, Sanofi’s Libtayo for first-line advanced NSCLC with high PD-L1 expression February 25, 2021
    (Sanofi) Feb 22, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Read more >
  • FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression February 22, 2021
    On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by...
  • Bayer and Tempus Initiate Collaboration to Enable Precision Medicine by Broadening Access to Genomic Testing February 11, 2021
    Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), announced a new collaboration designed to provide broader access to genomic testing for the oncology community. The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing a next-generation sequencing (NGS) based Tempus xT Solid Tumor assay at NO...
  • Now Approved as Early as 1st Relapse February 11, 2021
    XPOVIO® (selinexor) is now FDA approved in combination with bortezomib and dexamethasone (XVd) to treat adult patients with multiple myeloma who have received at least one prior therapy.1 The efficacy of XPOVIO in combination with Vd was evaluated in BOSTON, a global, randomized, open‑label, active‑controlled, phase 3 trial in adult patients who had received 1 to 3...
  • FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma February 11, 2021
    PARIS and TARRYTOWN, N.Y. – February 9, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with an hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted...
  • COVID-19 Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 – Drug Information Update February 11, 2021
    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk...
  • FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma February 10, 2021
    On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC)...
  • FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma February 9, 2021
    On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell...
  • FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma February 9, 2021
    Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the...
  • FDA Approves Karyopharm Therapeutics’ Selinexor for Refractory or Relapsed Multiple Myeloma February 5, 2021
    On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Read More HERE>>