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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Gavreto, a New RET Inhibitor, Now Approved for Thyroid Cancer with RET Fusions
FDA Approvals, News & Updates
,
Thyroid Cancer
December 2020, Vol 11, No 6
On
December 1, 2020
, the FDA accelerated the approval of a new indication for pralsetinib (Gavreto; Blueprint Medicines), a
RET
kinase inhibitor, for the treatment of patients aged ≥12 years with advanced or metastatic medullary thyroid cancer and
RET
mutation who require systemic therapy or for patients with thyroid cancer and
RET
fusion who require systemic therapy and whose tumor is refractory to radioactive iodine, if radioactive iodine is appropriate.
Read Article
Oral Onureg First Drug Approved for Adults with AML in Remission
FDA Approvals, News & Updates
,
Leukemia
December 2020, Vol 11, No 6
On
September 1, 2020
, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.
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Danyelza Receives FDA Approval for High-Risk Neuroblastoma in the Bone and Bone Marrow
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
On
November 25, 2020
, the FDA granted accelerated approval to naxitamab-gqgk (Danyelza; Y-mAbs Therapeutics), a GD2-binding monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients aged ≥1 year and adults who achieved a partial response, minor response, or stable disease after receiving previous therapy. The FDA granted naxitamab priority review and breakthrough therapy, orphan drug, and rare pediatric disease designations.
Read Article
FDA Approves First Prostate-Specific Membrane Antigen–Targeted PET Imaging Drug for Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
December 2020, Vol 11, No 6
On
December 1, 2020
, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels.
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Tecartus First CAR T-Cell Therapy FDA Approved for Patients with Mantle-Cell Lymphoma
FDA Approvals, News & Updates
October 2020, Vol 11, No 5
On July 24, 2020, the FDA accelerated the approval of brexucabtagene autoleucel (Tecartus; Kite Pharma), a CAR T-cell therapy, for the treatment of adults with mantle-cell lymphoma (MCL) whose disease has not responded to or has relapsed after other therapies. Brexucabtagene autoleucel is the first gene therapy FDA-approved specifically for the treatment of patients with MCL, a rare type of B-cell non-Hodgkin’s lymphoma.
Read Article
FDA Approves Monjuvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
FDA Approvals, News & Updates
October 2020, Vol 11, No 5
On July 31, 2020, the FDA accelerated the approval of tafasitamab-cxix (Monjuvi; Incyte/MorphoSys US), a CD19-directed cytolytic antibody, in combination with lenalidomide (Revlimid) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem-cell transplant.
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Blenrep, First BCMA Antibody, Receives FDA Approval for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
October 2020, Vol 11, No 5
On August 5, 2020, the FDA accelerated the approval of belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with relapsed or refractory multiple myeloma who have received ≥4 previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
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Gavreto, RET Inhibitor, FDA Approved for Metastatic NSCLC with RET Fusions
FDA Approvals, News & Updates
October 2020, Vol 11, No 5
On September 4, 2020, the FDA accelerated the approval of pralsetinib (Gavreto; Blueprint Medicines/Genentech), an oral RET inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and
RET
-activating fusions, as detected by an FDA-approved test.
Read Article
FDA News: August 2020
FDA Approvals, News & Updates
August 2020, Vol 11, Special Issue: Payers' Perspectives in Oncology
Inqovi First Oral Hypomethylating Agent Approved for Intermediate- or High-Risk Myelodysplastic Syndromes
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
Opdivo Now Approved for Advanced Esophageal Squamous-Cell Carcinoma
Cyramza plus Tarceva Approved for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
Tecentriq plus Avastin Combination Approved for First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma
Opdivo plus Yervoy and Limited Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
Read Article
Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma
FDA Approvals, News & Updates
Web Exclusives
On June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy. Nivolumab has been previously approved for many indications, but this is its first indication for esophageal cancer.
Read Article
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Home
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