Industry News Archive

  • 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 Crizotinib for Children and YA Patients with R/R ALCL

    On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

    Read the FDA announcement.

    Read Pfizer's announcement.

    Posted 1/15/2021



  • 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


  • Durvalumab Dosing Update

    Durvalumab (Imfinzi®, AstraZeneca) has been approved in the U.S. for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy. Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks.

    Read the press release.

    Posted on 12/15/2020. 



  • FDA Approves Additional Indication for Pembrolizumab

    Pembrolizumab (Keytruda®, Merck) has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

    Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:
    - locally recurrent unresectable or metastatic TNBC

    Read prescribing information and Medication Guide.

    Posted on 12/07/2020


     


  • Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine

    On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December. 


    Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021. 


    The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours. 


    Read Pfizer's announcement. Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP NewsNew York Times, and Washington Post


    Posted 11/20/2020



  • FDA Approves Pembrolizumab + Chemotherapy for TNBC

    On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda® (pembrolizumab) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

    Read the FDA announcement.

    Read the Merck press release.

    Posted 11/16/2020



1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
nos-nevada.com
Email Us