Industry News

  • FDA Approves FoundationOne®CDx to Identify MSI-H Solid Tumors

    Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne®CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda® (pembrolizumab).

    Read the Foundation Medicine announcement.

    Posted 2/22/2022



  • 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 FoundationOne®CDx as a Companion Diagnostic in Melanoma

    On December 8, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. 

    Read the Foundation Medicine announcement.

    Posted 12/8/2021



  • 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



  • 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



  • G1 Therapeutics Announces J-Code for Trilaciclib

    G1 Therapeutics announced the new permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Cosela™ (trilaciclib) issued by the Centers for Medicare & Medicaid Services (CMS). The code J1448 is effective October 1, 2021, for trilaciclib injection of 1mg for provider billing at all sites of care. 

    Read more on the Cosela website or G1 Therapeutics announcement.

    Posted 10/1/2021




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