Drugs

Clinical Benefit Not Proven with Lilly’s Lartruvo

Eli Lilly says results from ANNOUNCE, a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the therapy’s clinical benefit, which is a requirement for a product to demonstrate post approval under FDA’s accelerated approval program. Lartruvo, a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, was granted accelerated approval 10/2016.

“When stimulated, PDGF receptors cause tumor growth. Lartruvo works by blocking these receptors, which may help slow or stop tumor growth,” FDA said at the time of approval.

Lilly says the study “did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population.” It plans to present the ANNOUNCE data at an upcoming medical conference and will publish the results in a medical journal.

Because ANNOUNCE did not confirm clinical benefit, Lilly says it will work with global regulators to determine the appropriate next steps. “While these discussions are ongoing, patients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they are receiving clinical benefit,” it says. “For patients who have not previously received Lartruvo, the results of the Phase 3 trial do not support initiating treatment with Lartruvo in patients with STS, outside of participation in a clinical trial. At this time, Lilly is suspending promotion of Lartruvo.”

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