Drugs

Labeling Changes Approved for 2 Hedgehog Inhibitors

FDA says it has approved labeling changes for vismodegib (Genentech’s Erivedge) and glasdegib maleate (Pfizer’s Daurismo) to include information on musculoskeletal adverse reactions and recommendations to obtain baseline serum creatine kinase (CK) and monitoring of CK levels. The announcement of the labeling changes is in the agency’s response to an 8/31/2020 petition submitted by Dr. Meenal Kheterpal seeking such changes in all currently approved Hedgehog inhibitor drug products and any approved in the future.

Hedgehog inhibitors, an important class of anti-cancer drugs, are defined as small molecules that inhibit the activity of a component of what is known as the Hedgehog signaling pathway. The pathway takes its name from its polypeptide ligand, an intracellular signaling molecule called Hedgehog found in some fruit flies. Inhibition of the Hedgehog signaling pathway is said to be a potentially useful strategy for restricting tumor growth and for preventing the recurrence of the disease post-treatment.

FDA granted the petition in part and denied it in part because one Hedgehog inhibitor, Sun Pharma’s Odomzo (sonidegib phosphate) already had the information in its labeling. “To align the labeling more closely across the Hedgehog inhibitor class,” the letter says, “today we approve the labeling for vismodegib and glasdegib maleate to include further information on musculoskeletal adverse reactions and CK monitoring.”

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