SITC Reacts to FDA Approval of First PD-1 Blocking Drug for Melanoma

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With the news of the U.S. Food and Drug Administration (FDA) granting accelerated approval to Keytruda (pembrolizumab) for advanced melanoma, leaders from the Society for Immunotherapy of Cancer (SITC) are weighing in and the organization has plans to update its melanoma guidelines.

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...The impact of cancer immunotherapy is significant because not only can it lead to durable responses but it also comes with a favorable safety profile, said SITC Vice President Howard Kaufman, MD.

With the news of the U.S. Food and Drug Administration (FDA) granting accelerated approval to Keytruda (pembrolizumab) for advanced melanoma (*), leaders from the Society for Immunotherapy of Cancer (SITC) are weighing in and the organization has plans to update its melanoma guidelines.

“This is a very exciting announcement for patients with melanoma. The impact of cancer immunotherapy is significant because not only can it lead to durable responses but it also comes with a favorable safety profile. At the end of the day, the FDA approval of pembrolizumab offers physicians and their patients another approach to treating melanoma, which is increasing at a faster rate than almost any other kind of cancer,” explained SITC Vice President Howard Kaufman, MD.

“In fact, once it spreads, melanoma survival rates tend to be less than a year. With the approval of a treatment like Keytruda, we can anticipate longer life expectancies.”

There have been five FDA approvals for melanoma since 2011, but Keytruda is the first treatment of its kind. Specifically, it is the first FDA approved drug that blocks a cellular pathway called PD-1, keeping a person’s immune system from attacking melanoma cells. It is intended to be used following treatment with a type of cancer immunotherapy called ipilimumab.

According to an FDA press release (*), it “granted Keytruda breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies.”

SITC will now update its melanoma guidelines to reflect the approval and availability of Keytruda.

Additional information on cancer immunotherapy is available at the SITC website.

About SITC
Founded in 1984, Society for Immunotherapy of Cancer (SITC) is a non-profit medical society dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy through the core values of interaction, innovation and leadership. For more information on SITC, visit the Society website at: http://www.sitcancer.org.

(*) Link to source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm

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Angie Kilbert
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