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RICHARD CARVAJAL: So because of the activity that we saw in ARTISTRY-1 and mucosal melanoma, the decision was made to pursue this further in that indication. And mucosal melanoma, because it is a rare disease, it is given some accommodations by the FDA.

And so one of those accommodations is orphan drug designation, right, which provides benefits to the development program in terms of access to the FDA, and some financial considerations as well, given the small market size should this drug be approved. Again, we're talking maybe 1,500 cases a year in the United States, all told, new diagnoses. So it's a very small market share.

I think those sorts of accommodations are really, really important for the rare cancer field. as you might imagine, I think it's a clearer path in terms of financial decisions for pharma to go after the more common cancers, lung cancer, prostate cancer, colon cancer, breast cancer certainly. And those incentives are a little bit less with the less common cancers.

And yet, more often than not, the less common cancers are the ones that are in perhaps more significant need for some of these novel therapies. And so this is a big issue, I think, in the entire cancer field, particularly as we understand that the different molecular subsets of the various diseases we're treating, and as we subdivide and subdivide and subdivide cancers into different histologic subsets or molecular subsets with frequently different biologies and different responses to therapies and different clinical courses.

I think this problem is going to become only more important. And kind of studying those subsets, and understanding that biology, even in a rare indication, I think can accelerate development in perhaps more common diseases.

Video

On the basis of what early clinical data, safety profile, and mechanistic features does the FDA typically approve a drug such as nemvaleukin for fast track designation?


Created by

CMEducation Resources | iQ&A Cytokine Immunotherapy Intelligence Zone

Presenter

Richard Carvajal, MD

Richard Carvajal, MD

Deputy Physician-in-Chief and Director of Medical OncologyRoy J. and Tara Zuckerberg Professor in Medical OncologyNorthwell Health Cancer InstituteLake Success, NY