Drugs

FDA Approves Halaven for Liposarcoma Treatment

FDA has approved Eisai’s Halaven (eribulin mesylate) for treating unresectable or metastatic liposarcoma in patients who received prior chemotherapy containing an anthracycline drug. An agency news release says the drug’s safety and efficacy were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes or other parts of the body and who had been treated with chemotherapy.

Trial patients were treated with either Halaven or dacarbazine until their disease spread or until they were no longer able to tolerate treatment side effects. The median overall survival time for patients treated with Halaven was 15.6 months, compared to 8.4 months for those receiving dacarbazine.

The most common side effects among patients treated with Halaven were fatigue, nausea, hair loss, constipation, peripheral neuropathy, abdominal pain, and fever. It also may cause neutropenia or decreased levels of potassium or calcium. FDA says that serious side effects from Halaven treatment may include a decrease in white blood cell count, neuropathy, harm to a developing fetus, and QTc prolongation, that may also lead to death.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome