In the News: Oncology
- FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
- FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
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.
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.
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.
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.
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).
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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Results 1 - 10 of 35
Results 1 - 10 of 35