Industry News

  • 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


  • New Permanent J-Code for Melphalan Flufenamide

    Oncopeptides announces J-code J9247 for Pepaxto® (melphalan flufenamide) injection, 1mg. This J-code will be effective on October 1, 2021.



  • FDA Approves Nivolumab for High-Risk Urothelial Carcinoma

    On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab—240 mg every two weeks or 480 mg every four weeks—for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.

    Read the FDA announcement.

    Posted 8/20/2021



  • FDA Approves Belzutifan for von Hippel-Lindau Disease-Associted Tumors

    On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

    Read the FDA announcement.

    Read the Merck announcement.

    Posted 8/16/2021



  • FDA Approves Levnatinib + Pembrolizumab for Advanced RCC

    On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

    Read the FDA announcement.

    Read the Eisai announcement.

    Posted 8/16/2021



  • FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

    On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

    Read Merck's announcement.

    Posted 7/27/2021



  • FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

    On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, 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 the Merck announcement.

    Read the Eisai Inc. announcement

    Posted 7/22/2021




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