Industry News

  • FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

    On February 3, 2023, the U.S. Food and Drug Administration (FDA) approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    Click here to review the data.

    Please see full Prescribing Information including BOXED WARNING.

    TRODELVY-123x50  Gilead-125x50

    TRODELVY, the TRODELVY logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies.

    ©2023 Gilead Sciences, Inc. All rights reserved. US-TROP-0782 02/23



  • FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC

    On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

    For more information read the FDA announcement and the Merck announcement

    Posted 1/27/2023



  • FDA Approves Tremelimumab with Durvalumab + Chemotherapy for Metastatic NSCLC

    On November 10, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations.

    For more information, read the FDA announcement.

    Posted 11/15/2022



  • FDA Approves Tremelimumab in Combination with Durvalumab for Unresectable HCC

    On October 21, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (HCC). 

    For more information, read the FDA announcement and the AstraZeneca announcement

    Posted 10/24/2022



  • FDA Approves Durvalumab + Gemcitabine for Biliary Tract Cancer

     On September 2, 2022, the U.S Food and Drug Administration (FDA) durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. 

    For more information, read the FDA announcement, and the AstraZeneca announcement

    Posted 9/8/2022

     



  • GSK Shares Plans to Voluntarily Withdraw Niraparib

    GlaxoSmithKline (GSK) is planning to voluntarily withdraw the indication of niraparib for treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

    For more information read the GSK letter.

    Posted 9/7/2022



  • CMS Delays Radiation Oncology Model For Further Rulemaking

    On August 29, 2022, the Centers for Medicare & Medicaid Services (CMS) published a final rule (CMS-5527-F2) that finalized delaying the Radiation Oncology Model start date until a date is determined through future rulemaking.

    For more information, visit the Radiation Oncology Model website.

    Posted 8/30/2022



  • FDA Approves Ibrutinib for Pediatric Patients with Chronic Graft-Versus-Host Disease

    On August 24, 2022, the U.S  Food and Drug Administration (FDA) approved ibrutinib for the treatment of pediatric patients one year and older with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. 

    For more information, read the FDA announcement

    Posted 8/25/2022



  • FDA Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

    On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

    For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

    Posted 8/15/2022



  • FDA Approves Capmatinib for Metastatic NSCLC

    On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

    For more information, read the FDA announcement.

    Posted 8/15/2022



  • FDA Approves New Acalabrutinib Formulation

    On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

    For more information, read AstraZeneca's announcement.

    Posted 8/12/2022



  • Important Update: Olaparib in 4th Line Treatment of Ovarian Cancer

    AstraZeneca has issued a letter with plans to withdraw its indication for olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. This planned withdrawal will not affect any of the maintenance therapy indications for olaparib or olaparib-based combinations.

    Read the letter

    Posted on 08/11/2022


  • FDA Approves Fam-Trastuzumab-Deruxtecan-nxki for HER2-Low Breast Cancer

    On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

    For more information, read the FDA announcement .

    Posted 8/5/2022



  • FDA Approves Tablet Formulation of Acalabrutinib

    On August 5, 2022, the Food and Drug Administration approved new tablet formulation of acalabrutinib (Calquence, AstraZeneca) under accelerated approval based on overall response rate for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and patients with relapsed or refractory mantle cell lymphoma.

    Read full press release

    Posted on 08/05/2022



  • BMS Launches DDiCT Initiative to Improve Healthcare Outcomes for People with Disabilities

    On July 20, 2022, Bristol Myers Squibb (BMS)—in collaboration with Disability Solutions—announced the launch of the Disability Diversity in Clinical Trials (DDiCT) initiative as part of its mission to address health disparities, clinical trial and supplier diversity, employee giving, and workforce representation between 2020 and 2025. 

    The DDiCT initiative initially aims to make recommendations on how to effectively improve access, engagement, speed of enrollment, and participation of people with disabilities in clinical trials, to ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies.

    For more information, read the press release.

    Posted on 7/21/2022 



  • FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib for adult and pediatric patients at least a year old, with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. 

    For more information, read the FDA announcement

    Posted 7/19/2022 



  • FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

    On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
    • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
    • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
    For more information, read the FDA announcement and Bristol Myers Squibb's announcement.

    Posted 6/28/2022


  • FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

    On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status. 

    For more information, read Bristol Myers Squibb's announcement.

    Posted 5/31/2022



  • FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

    On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

    For more information, read Novartis' announcement.

    Posted 5/31/2022



  • Fam-Trastuzumab Deruxtecan-Nxki Approved for Patients with HER2+ MBC

    Fam-Trastuzumab Deruxtecan-Nxki (Enhertu®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

    Read press release

    Posted 05/17/2022




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