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Ian Ingram | Authors
FDA Approves Abiraterone/Prednisone for Metastatic Prostate Cancer
February 08, 2018
The US Food and Drug Administration has approved abiraterone acetate (Zytiga) tablets in combination with prednisone for the treatment of metastatic prostate cancer patients with high-risk, castration-sensitive disease.
FDA Expands Approval of EGFR Inhibitor for Lung Cancer Treatment
January 17, 2018
The FDA has expanded the approval of afatinib (Gilotrif) to include the first-line treatment of metastatic non–small-cell lung cancer patients whose tumors have non-resistant EGFR mutations, including three newly identified substitution mutations.
FDA Approves First Drug for BRCA-Positive Breast Cancer
January 12, 2018
The FDA has expanded the approval of the PARP inhibitor olaparib (Lynparza) to include the treatment of patients with metastatic breast cancer who have a mutated BRCA gene.
FDA Approves Brentuximab Vedotin for Cutaneous Lymphoma
November 10, 2017
The FDA has approved brentuximab vedotin (Adcetris) for the treatment of primary cutaneous anaplastic large-cell lymphoma and CD30-expressing mycosis fungoides in patients who have received prior systemic therapy.
FDA Approves Vemurafenib for Treating Erdheim-Chester Disease
November 09, 2017
The FDA has expanded the approval of vemurafenib (Zelboraf) to include the treatment of Erdheim–Chester disease in adult BRAF V600–positive patients. This marks the first approval from the agency for treating this rare blood cancer.
FDA Approves Acalabrutinib for Mantle Cell Lymphoma
November 01, 2017
The FDA has granted accelerated approval to acalabrutinib (Calquence) for the treatment of mantle cell lymphoma in adult patients who have received at least one previous therapy.
FDA Approves CAR T-Cell Therapy for Adults With Aggressive Lymphomas
October 19, 2017
The FDA has approved the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) for the treatment of large B-cell lymphomas in adults who have failed or relapsed after two or more prior treatments.
FDA Approves Nivolumab for Treating Liver Cancer
September 26, 2017
The FDA has granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.
FDA Approves Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
September 16, 2017
The FDA has approved gemtuzumab ozogamicin (Mylotarg) for the first-line treatment of adults with CD33-positive AML and for pediatric patients with relapsed or refractory CD33-positive AML.
FDA Approves Copanlisib for Relapsed Lymphoma
September 14, 2017
The FDA has approved the novel PI3K inhibitor copanlisib (Aliqopa) for the treatment of relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.