Industry News

  • 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 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



  • 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 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



  • FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

    On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. 

    Read the FDA announcement.

    Read Novartis' announcement.

    Posted 3/24/2022



  • FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

    On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 3/22/2022


  • FDA approves nivolumab and relatlimab-rmbw for melanoma

    On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

    Read the FDA announcement.

    Read Bristol Myers Squibb's announcement.

    Posted 3/21/2022


  • 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


  • 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 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 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 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



  • FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

    On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.

    Read the FDA announcement.

    Read BeiGene's announcement.

    Posted 9/7/2021



  • FDA Approves Updated Pembrolizumab Indication for UC

    On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved a label update to pembrolizumab for first-line advanced urothelial carcinoma (UC). This approval converts the accelerated approval of pembrolizumab to a regular approval.

    Read Merck's announcement.

    Posted 9/1/2021



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