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Industry News Archive

  • 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



  • Do Good Initiative: Share Your Insights!

    As part of Breast Cancer Awareness month, Sanofi has launched a "Do Good" initiative where treatment insights will be gathered from healthcare providers through a brief survey. Once completed by a breast cancer treating professional, a $50 donation will be made by Sanofi to a patient advocacy group that supports underserved metastatic breast cancer patients. To greater the impact, Sanofi will match the donation made on behalf of the professional, which we believe will deliver more Good & further help underserved breast cancer patients.

    Please take a moment to complete the survey and share your insights.

    Complete Survey

    Posted on 11/15/2021



  • 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



  • FDA Approves Brexucabtagene Autoleucel for R/R B-Cell Precursor ALL

    On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

    Read the FDA announcement.

    Read Kite Pharma's announcement.

    Posted 10/4/2021



  • FDA Expands Cetuximab in Combination Label for Metastatic Colorectal Cancer

    On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

    Read Eli Lilly's announcement.

    Posted 9/29/2021



  • FDA Approves Cabozantinib for Locally Advanced or Metastatic DTC

    On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.

    Read the FDA announcement.

    Read Exelixis' announcement.

    Posted 9/20/2021



  • FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations

    On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

    Read the FDA announcement.

    Read Takeda's announcement.

    Posted 9/16/2021



  • FDA Grants Accelerated Approval to Zanubrutinib for R/R MZL

    On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

    Read the FDA announcement.

    Read BeiGene's announcement.

    Posted 9/15/2021




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