Drugs

Pfizer’s Tukysa Meets Trial Endpoint

Pfizer says its Tukysa (tucatinib) achieved a statistically significant and clinically meaningful improvement in progression-free survival in the HER2CLIMB-05 trial evaluating Tukysa versus placebo, both in combination with first-line standard of care maintenance therapy (Genentech’s Herceptin (trastuzumab) plus Genentech’s Perjeta (pertuzumab) following chemotherapy-based induction in patients with HER2+ metastatic breast cancer. A Pfizer statement says treatment with Tukysa in combination with Herceptin and Perjeta was tolerable, with a safety profile generally consistent with the established safety profiles of each individual drug.

Tukysa is described as an orally administered tyrosine kinase inhibitor of HER2 that has been approved in combination with Herceptin and Genentech’s Xeloda (capecitabine) to treat adults with HER2+ advanced unresectable or metastatic breast cancer, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

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