Drugs

FDA Safety Review on Gilead’s Zydelig After Triall Deaths

FDA says it is evaluating the safety of Gilead Sciences 2014-approved Zydelig (idelalisib), indicated for treating patients with three types of blood cancers, after receiving reports of deaths in clinical trials involving the drug. “The safety of patients is a top priority and the FDA will communicate new safety-related information on Zydelig as it becomes available,” an agency spokeswoman told FDA Webview 3/11. “The FDA urges health care professionals and patients to report adverse events involving Zydelig to the FDA MedWatch program,” she said. “Patients should talk with their doctor if they have concerns about any drug they are prescribed and its risks.”

FDA’s acknowledgment of the safety review comes on the heels of an EMA 3/11 notice announcing a similar safety review in Europe. “The review has been started because an increased rate of serious adverse events including deaths, mostly due to infections, was seen in three clinical trials investigating the medicine in combination with other cancer medicines,” EMA said. “The clinical trials involved patients with chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukaemia investigated combinations of medicines that are currently not approved and the studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indications. Investigators of all clinical trials involving Zydelig are currently being informed of the actions to be taken in relation to the conduct of ongoing studies.”

In 2014, FDA granted the drug traditional approval to treat patients whose chronic lymphocytic leukemia has relapsed, and accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma. The approval required a boxed warning alerting patients and health care professionals to fatal and serious toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis) and intestinal perforation that can occur in Zydelig-treated patients, FDA said at the time. Zydelig also has a Risk Evaluation and Mitigation Strategy comprised of a communication plan to ensure healthcare providers who are likely to prescribe Zydelig are fully informed about these risks.

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