Drugs

Aveo Phase 3 Trial Misses Primary Endpoint

Aveo Oncology says its TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma whose tumors had progressed following prior immune checkpoint inhibitor treatment did not meet the primary endpoint of increasing progression-free survival when nivolumab (Bristol Myers Squibb’s Opdivo) was added to low-dose Fotivda (tivozanib). A company statement says the trial’s control arm using Fotivda as monotherapy demonstrated a clinically meaningful outcome in median progression-free survival in the second-line following immune checkpoint inhibitor (ICI) combination therapy.

Aveo says the results are consistent with other recent Phase 3 renal cell carcinoma trials in a similar patient population that suggested there is no clinical benefit in rechallenging patients with immunotherapy after receiving ICI beyond progression on previous ICIs.

Fotivda is described as an oral, next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor. FDA approved it 3/10/21 to treat adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.

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