The shares of Merck & Co., Inc. (NYSE:MRK) are trading higher after revealing that it started submitting a rolling application to the United States Food and Drug Administration (FDA) to obtain an early approval of its new cancer drug.
The stock price of Merck & Co., Inc. (NYSE:MRK) rose more than 6% to $53.02 per share at the time of this writing, around 2:00 P.M. in New York.
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Treatment for patients with advanced melanoma
The pharmaceutical company said it is applying for a biologics license for MK-3475, an investigational anti-PD-1 immunotheraphy for patients suffering from advanced melanoma who were previously treated with ipilimumab. According Merck & Co., Inc. (NYSE:MRK) its rolling submission allows the FDA to review the completed portions of its application on an ongoing basis. It expects to complete its application in the first half of this year.
In a statement, Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories said, “Our MK-3475 is a novel immunomodulatory molecule that holds promise for patients with advanced malignancy who now have limited treatment options.”
“Initiation of this rolling submission represents an important milestone in the MK-3475 clinical development program for patients suffering from malignant melanoma,” added Dr. Perlmutter.
Currently, Merck & Co., Inc. (NYSE:MRK) is conducting three clinical trials for MK-3475 for advanced melanoma including a Phase III trial of the drug compared with ipilimumab in ipilimumab-naïve advanced melanoma patients (PN 006).
The pharmaceutical company said the enrollment for its advanced melanoma cohorts for the Phase IB trial (PN 001) and the Phase II trial (PN 002) comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy are already complete.
Merck & Co., Inc. (NYSE:MRK) received a breakthrough designation for the MK-3475 for advanced melanoma from the FDA in April last year.
Encouraging news for Merck
Mark Schoenebaum, analyst at International Strategy & Investment Group LLC commented that the news regarding the rolling application of Merck & Co., Inc. (NYSE:MRK) for its new cancer treatment is encouraging. He said, “The news today in advanced melanoma is encouraging, the larger market opportunity for PD1/PDL1 antibodies is in lung cancer and other tumors.”