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In the News
FDA Approves Rucaparib and Companion Diagnostic for Patients with Advanced Ovarian Cancer
FDA Updates
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In the News
Web Exclusives
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
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Daratumumab Combination Approved for Multiple Myeloma
FDA Updates
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In the News
Web Exclusives
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
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Pembrolizumab Approved for Patients with Head and Neck Cancer
FDA Updates
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In the News
Web Exclusives
The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda injection) for use in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-containing chemotherapy. The injection is recommended to be administered at 200 mg intravenously for 30 minutes every 3 weeks.
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Monthly Injection Approved for Patients with Relapsed Multiple Sclerosis
FDA Updates
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In the News
Web Exclusives
Daclizumab (Zinbryta) has been approved by the US Food and Drug Administration for adults with relapsing forms of multiple sclerosis. The drug is self-administered by the patient monthly, and comes in the form of a long-acting injection.
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Netspot Approved for Detection of Neuroendocrine Tumors
FDA Updates
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In the News
Web Exclusives
The US Food and Drug Administration has approved Netspot, the first kit for preparation of gallium Ga 68 dotatate injection, for the detection of neuroendocrine tumors in adult and pediatric patients. The injection serves as a radioactive diagnostic agent for positron emission tomography imaging.
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First EGFR Mutation Blood Test Approved for Patients with NSCLC
FDA Updates
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In the News
Web Exclusives
The first blood test for detecting epidermal growth factor receptor (EGFR) gene mutations in patients with non−small-cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration. The cobas EGFR Mutation Test v2 is a blood-based diagnostic that aids in selecting patients with NSCLC who may benefit from treatment with erlotinib (Tarceva).
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Atezolizumab Approved for Patients with Advanced or Metastatic Urothelial Carcinoma
FDA Updates
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In the News
Web Exclusives
Atezolizumab injection (Tecentriq) has been approved by the US Food and Drug Administration for patients with locally advanced or metastatic urothelial carcinoma with disease progression after or ≤12 months of receiving platinum-containing chemotherapy. The recommended dosage of the drug, which is programmed death-ligand 1 blocking antibody, is 1200 mg administered intravenously every 3 weeks until disease progression or unacceptable toxicity.
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Nivolumab Approved for Patients with Relapsed, Refractory Classical Hodgkin Lymphoma
FDA Updates
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Hematologic Cancers
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In the News
Web Exclusives
The US Food and Drug Administration has approved nivolumab (Opdivo) for patients with classical Hodgkin Lymphoma that has progressed or relapsed following autologous hematopoietic stem cell transplantation and post-transplant brentuximab vedotin, according to an announcement by the agency. Notably, the intravenous drug was granted accelerated approval, and Breakthrough Therapy Designation.
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Lenvatinib Approved for Use with Everolimus for Treating Advanced Renal Cell Carcinoma
FDA Updates
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In the News
Web Exclusives
Lenvatinib capsules (Lenvima) have been approved in combination with everolimus in patients with advanced renal cell carcinoma who have had 1 previous anti-angiogenic therapy, according to an announcement by the US Food and Drug Administration. The combination has demonstrated greater progression-free and overall survival rates, compared with lenvatinib monotherapy.
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Venclexta FDA Approved for Patients with CLL
FDA Updates
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In the News
Web Exclusives
Venetoclax (Venclexta) has been approved by the US Food and Drug Administration (FDA) for daily use in patients with chronic lymphocytic leukemia (CLL) who have 17p deletion, and had ≥1 prior therapies, according to an announcement by the agency. This drug is the first treatment that targets the B-cell lymphoma 2 protein, which is overexpressed in many patients with CLL.
Read More ›
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