Web Exclusives
On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults. Read More ›
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis) for the treatment of patients with advanced renal-cell carcinoma (RCC) who had received anti-angiogenic therapy. Read More ›
On October 18, 2016, atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, was approved by the FDA for patients with metastatic non–small-cell lung cancer (NSCLC) associated with the EGFR or ALK genetic mutations whose disease progressed during or after treatment with platinum-containing chemotherapy. Read More ›
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. Read More ›
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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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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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). Read More ›
- Acalabrutinib Demonstrates Efficacy and Safety in Relapsed CLL
- Atezolizumab Shows Durable Response, Tolerability in Urothelial Carcinoma
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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