Drugs

FDA Approves AstraZeneca’s Imfinzi in Lung Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. This is the first treatment approved for this disease stage to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation, FDA Oncology Center of Excellence Richard Pazdur says in a release. “Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress,” he says. “Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”

Approval was based on data from a randomized trial of 713 patients. “The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for patients receiving a placebo,” FDA says. In addition, AstraZeneca agreed to a post-marketing commitment to provide additional information from their study about how long patients lived following treatment with Imfinzi after chemotherapy and radiation (overall survival).

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