Industry News

  • 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



  • FDA Approves Expanded Indication for Pembrolizumab for cSCC

    On July 6, 2021, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab as a monotherapy treatment for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

    Read Merck's announcement.

    Posted 7/6/2021


  • FDA Approves Sotorasib for KRAS G12C-Mutated NSCLC

    The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRASTM, Amgen) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib has received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Read press release.

    Posted on 6/1/2021



  • FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

    On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 5/21/2021



  • FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

    The Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

    Read the prescribing information and medication guide.

    Posted on 4/30/2021



  • FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

    On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

    Read the FDA announcement.

    Read the BMS announcement.

    Posted 4/16/2021



  • FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

    On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Read the bluebird bio, Inc. announcement.

    Posted 3/29/21



  • FDA Approves Trastuzumab-qyyp Biosimilar

    The U.S. Food and Drug Administration approved the 150 mg single-dose vial of trastuzumab-qyyp (Trazimera®, Pfizer)—a biosimilar to Herceptin® (trastuzumab).

    Read the full prescribing information.

    Posted on 3/11/2021



  • FDA Approves Bevacizumab-bvzr for New Indication

    The U.S. Food and Drug Administration approved the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of bevacizumab-bvzr (Zirabev®, Pfizer). 

    Read the full prescribing information.

    Posted on 3/11/2021



  • FDA Approves Melphalan Flufenamide for R/R MM

    On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

    Read Oncopeptides' announcement.

    Posted 3/1/21



  • FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

    On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 2/8/2021


  • New FDA-Approved Indication for Crizotinib Capsules

    The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

    Read the Full Prescribing Information.

    Read the Press Release.

    Posted 1/26/2021



  • FDA Approves Nivolumab + Cabozantinib for Advanced RCC

    On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

    Read Bristol Myers Squibb's announcement.

    Read the FDA announcement.

    Posted 1/22/2021



  • Registration Open: Jakafi (ruxolitinib) Product Theater

    Intervening With Jakafi® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

    incyte-logoJakafi® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

    Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi® (ruxolitinib) in treating your patients. 

    Monday, November 30
    12:00 - 1:00 PM EST

    Presented by:
    Solomon Hamburg, MD, PhD
    Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
    UCLA Beverly Hills Hematology Oncology
    REGISTER

    Monday, November 30
    3:00 - 4:00 PM EST

    Presented by:
    Jonathan Abbas, MD
    Director, Acute Leukemia Program
    Tennessee Oncology
    REGISTER



  • FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

    On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

    The target action date for the FDA decision is February 28, 2021.

    Read press release

    Posted on 10/29/2020.



  • FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

    On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.

    Read Merck's press release and the FDA announcement.

    Posted 10/15/2020



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