Industry News Archive

  • 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 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



  • FDA Approves Melphalan Flufenamide for R/R MM

    On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

    Read Oncopeptides' announcement.

    Posted 3/1/21



  • FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

    On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel 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 lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 2/8/2021


  • FDA Approves Tepotinib for Metastatic NSCLC

    On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.

    This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Read the FDA announcement.

    Read Merck KGaA's announcement.

    Posted 2/4/21



  • New FDA-Approved Indication for Crizotinib Capsules

    The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

    Read the Full Prescribing Information.

    Read the Press Release.

    Posted 1/26/2021



  • FDA Approves Nivolumab + Cabozantinib for Advanced RCC

    On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

    Read Bristol Myers Squibb's announcement.

    Read the FDA announcement.

    Posted 1/22/2021



  • FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 12/21/2020



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