Merck´s new cancer treatment receives FDA approval
The US Food and Drug Administration calls Merck´s new product a "breakthrough therapy".

The U.S. The Food and Drug Administration (FDA) has given Merck & Co. the designation "Breakthrough Therapy". (NYSE: MRK) granted the name of the novel HIF-2α inhibitor MK-6482. The product is a novel test candidate and one of Merck's oncology products is intended to be used in the treatment of "Patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless because immediate surgery is required ". In a statement by Dr. Scot Ebbinghaus, Vice President, Clinical Research, told Merck Research Laboratories the company's main agenda is to develop innovative treatments that meet the needs of all patients. FDA breakthrough therapy designation is granted to pharmaceutical companies to expedite the development and review of drugs that have been proposed for the treatment of severe or life-threatening conditions. Designation will be offered to drugs that have provided preliminary clinical evidence that the drug has the potential therapy in at least one clinically meaningful endpoint. On the other hand, the FDA will grant orphan drug status to drugs intended to treat, prevent, and diagnose a rare disease that affects fewer than 200,000 people in the United States. According to the company, its primary role is to translate breakthrough science into innovative oncological treatments that can be used by cancer patients around the world. In addition, the company claims to be researching the potential of immuno-oncology. Merck is also strengthening its portfolio through strategic acquisitions and is focusing on developing several promising oncology candidates. Last week, Merck was bullish on its worst-case scenario for full-year earnings when the company began receiving patients who were previously in lockdown. The company forecast core earnings before special items of between EUR 4.45 billion and EUR 4.85 billion for 2020. This is an increase from an earlier forecast of 4.35 billion euros. The company said the projections are based on the assumption that there would be no further lockdowns due to a second wave of infections. Another lockdown would have negative consequences for the economic recovery.



