HIF-2α inhibitor MK-6482 receives FDA Breakthrough Designation for Von Hippel-Lindau Disease-associated RCC

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

The hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate, received Breakthrough Designation from FDA for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.

HIF-2α inhibitor MK-6482 is sponsored by Merck.

FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a phase II trial evaluating MK-6482 in patients with VHL-associated clear cell RCC.

Table of Contents

YOU MAY BE INTERESTED IN

Shearwood McClelland III’s grandfather was a ditchdigger who dreamed that his six Black daughters would become doctors. McClelland’s mother did not disappoint—she became the first Black woman board-certified in maternal fetal medicine in the history of the United States.  Now, McClelland is the chief medical officer of Cancer Health Equity at the University of Oklahoma...

As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments.  Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...

In the evolving landscape of pediatric oncology, survivorship research has become an essential component of our mission to improve long-term patient outcomes. At City of Hope, we are focused on not only curing childhood cancers but also ensuring that survivors live the healthiest lives possible. A significant part of my research has been dedicated to mitigating the long-term toxicities of cancer therapy—particularly cardiovascular complications that can arise decades after treatment.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login