Drug Profile: KEYTRUDA
1. Introduction
KEYTRUDA (MK-3475) is a blockbuster immune modulator by Merck for patients with advanced stages of malignancy. The U.S. FDA has assigned MK-3475 a Breakthrough Therapy Designation for Metastatic Melanoma. It is a humanized monoclonal IgG4 antibody against human cell surface receptor PD-1. KEYTRUDA is the 6th approved drug for melanoma and is indicated for patients who have undergone prior treatment with ipilimumab. It has been approved in Japan, while Priority review designation for MK-3475 was permitted by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) date of 28 October 2014
Alternate names: KEYTRUDA, Pembrolizumab/MK 3475
2. Incidence of melanoma
Melanoma is the most prevalent type of
…show more content…
Clinical trial results
Results of a clinical trial involving 173 patients who failed the treatment of Ipilimumab, gave Keytruda its breakthrough designation. Patients were administered a dose of 2 milligrams per kilogram (mg/kg) or a higher dose of 10 mg/kg. It was observed that in nearly 24% of the patients, the tumour had shrunk and this condition lasted from 1.4 to 8.5 months. However, patients with advanced melanoma experienced side effects of the drug which included fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain and diarrhea.
6. Patent