Drugs

FDA Approves Genentech’s Phesgo for Breast Cancer

FDA has approved Genentech’s Phesgo (pertuzumab, trastuzumab, and hyaluronidase ZZXF) for injection under the skin to treat adult patients with metastatic HER2-positive breast cancer, and for treating adult patients with early HER2-positive breast cancer. An agency announcement says patients should be selected based on an FDA-approved companion diagnostic test.

The announcement says the therapeutic components in Phesgo are the same as those in FDA-approved IV pertuzumab and IV trastuzumab. Phesgo offers patients the opportunity to be treated as an outpatient at home rather than at an infusion center, the agency says.

Approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which FDA says demonstrated Phesgo had comparable efficacy and safety as the IV formulations, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous administration route.

Phesgo labeling includes a Boxed Warning about the risk of potential heart failure, fetal harm, and lung toxicity. The most common side effects were listed as alopecia, nausea, diarrhea, anemia, and asthenia.

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