Industry News Archive

  • FDA Approves Olaparib for High-Risk Early Breast Cancer

    On Friday, March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 3/14/2022


  • FDA Approves Nivolumab in Combination for Early-Stage NSCLC

    On Friday, March 4, 2022, the U.S. Food and Drug Administration approved nivolumab with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.

    Read the FDA announcement.

    Read Bristol Myers Squibb's announcement.

    Posted 3/7/2022


  • Servier Announces New NDC Number for Ivosidenib

    Starting today, February 14, 2022, Tibsovo® (ivosidenib tablets) will use NDC number 72694-0617-6 for ordering. Though the product packing has changed, Servier ensures the product and ordering process remain the same.

    For more information, visit the Tibsovo website.

    Posted 2/14/2022


  • New Clinical Trial for Patients with Tumors Harboring NRG1 Fusions

    New clinical trial in patients suffering from tumors harboring NRG1 gene alterations, specifically NRG1 gene fusion-positive advanced solid tumors. 

    To learn more about a prospective real-world outcomes study in patients with tumors harboring NRG1 fusions, click here.

    Posted on 12/09/2021.


  • FDA Approves Rituximab + Chemotherapy for Pediatric Cancer Indications

    On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. 

    Read the FDA announcement.

    Posted 12/6/2021



  • FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

    On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 12/6/2021



  • FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

    On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 11/18/2021



  • FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

    On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

    Read the FDA announcement.

    Read Novartis' announcement.

    Posted 11/1/2021



  • FDA Approves Pembrolizumab Combination for Cervical Cancer

    On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. 

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 10/14/2021



  • FDA Approves Abemaciclib with Endocrine Therapy for Early Breast Cancer

    On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test. 

    Read the FDA announcement.

    Read Eli Lilly and Company's announcement.

    Posted 10/14/21




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