Categorized | Melanoma News, Regulatory

FDA grants fast track designation to ImmunoPulse IL-12 for melanoma

Source: Healio, February 2017

The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,” Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. “Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.”

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