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Industry News Archive

  • Positive Phase 3 Cemiplimab Results in Advanced Cervical Cancer

    On Wednesday, May 12, Regeneron Pharmaceuticals, Inc. and Sanofi announced the presentation of positive results from the Phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo®) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.

    The data were shared as part of a European Society for Medical Oncology Virtual Plenary and add to previously reported data showing an improvement in overall survival (OS) with Libtayo compared to chemotherapy. The data will form the basis of regulatory submissions in 2021.

    Read the press release.

    Posted on 5/12/2021



  • [Virtual Panel] MDT Approaches to Treating Unresectable Stage III NSCLC

    Thursday, May 6
    6:00 - 7:15 PM PST

    Hosted by AstraZeneca, this virtual panel discussion will focus on multidisciplinary (MDT) approaches to treating patients with unresectable stage III NSCLC. 

    Meet the Panelists:
    Ronald Natale, MD
    Director, Lung Cancer Clinical Research Program
    Samuel Oschin Comprehensive Cancer Institute
    Professor of Medicine, Division Hematology/Oncology
    Cedars-Sinai Medical Center
    Los Angeles, CA

    Arya Amini, MD
    Assistant Professor, Chief of Thoracic Radiotherapy
    City of Hope National Medical Center
    Duarte, CA

    Jed Gorden, MD, FCCP
    Director of Interventional Pulmonology; Director Center Lung Research in Honor of Wayne Gittinger
    Department of Thoracic Surgery and Interventional Pulmonology
    Swedish Cancer Institute
    Seattle, WA

    REGISTER


  • FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

    The Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

    Read the prescribing information and medication guide.

    Posted on 4/30/2021



  • [Virtual Webcast] African American Experience in Multiple Myeloma

    Thursday, May 13
    3:00 - 4:00 PM PDT/6:00 - 7:00 PM EDT


    Brought to you by Oncopeptides, this presentation will feature a panel of experts discussing key data around the African American Experience in Multiple Myeloma and strategies to remove disparities and barriers to care, followed by a Q&A session. This is not a promotional event—Pepaxto will not be discussed on this webinar.

    REGISTER

    Posted on 4/27/2021



  • FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for R/R LBCL

    On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl for adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

    Read the FDA announcement.

    Read ADC Therapeutics announcement.

    Posted 4/26/2021



  • FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

    On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

    Read the FDA announcement.

    Read the BMS announcement.

    Posted 4/16/2021



  • FDA Approves Isatuximab in Combination for R/R Multiple Myeloma

    On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received one to three prior lines of therapy.

    Read the FDA announcement.

    Read the Sanofi announcement.

    Posted 4/1/2021



  • FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

    On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Read the bluebird bio, Inc. announcement.

    Posted 3/29/21



  • FDA Approves Trastuzumab-qyyp Biosimilar

    The U.S. Food and Drug Administration approved the 150 mg single-dose vial of trastuzumab-qyyp (Trazimera®, Pfizer)—a biosimilar to Herceptin® (trastuzumab).

    Read the full prescribing information.

    Posted on 3/11/2021



  • FDA Approves Bevacizumab-bvzr for New Indication

    The U.S. Food and Drug Administration approved the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of bevacizumab-bvzr (Zirabev®, Pfizer). 

    Read the full prescribing information.

    Posted on 3/11/2021




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