The US Food and Drug Administration (FDA) has accepted Merck’s biologics licence application for review of its MK-3475, an investigational anti-PD-1 antibody, for advanced melanoma.
The investigational anti-PD-1 antibody is designed for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab.
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Priority review designation for MK-3475 was granted by the FDA with a Prescription Drug User Fee Act date of 28 October 2014. The agency will review Merck’s MK-3475 biologics licence application under its accelerated approval programme.
MK-3475 was previously granted breakthrough therapy designation by the FDA for advanced melanoma.
According to Merck, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators if approved by the FDA.
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Merck is also planning to file a marketing authorisation application in Europe by the end of this year for MK-3475 for advanced melanoma treatment.
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By GlobalDataMerck Research Laboratories president Dr Roger Perlmutter said that patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments.
"We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options," Dr Perlmutter added.
Merck has also highlighted progress on the advancement of the MK-3475 development programme,- currently ongoing in 30 tumour types as monotherapy and in combination.
The company expects that by the end of the year this development programme will increase to more than 24 clinical trials across 30 different tumour types, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide, including four new Phase III studies.
Ongoing and planned late-stage monotherapy and combination studies include seven Phase III registrational trials and ten combination studies.
The seven Phase III registrational trials cover advanced melanoma (adjuvant, ipilimumab-naïve, and ipilimumab-refractory), advanced non-small cell lung cancer (NSCLC) (previously treated and previously untreated), advanced head and neck cancer, and advanced bladder cancer.
The ten combination studies cover advanced melanoma, advanced NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other solid tumours.
Image: Histopathologic image of malignant melanoma. Photo: courtesy of KGH.
