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FDA grants ‘breakthrough’ designation for lambrolizumab
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The FDA granted breakthrough therapy designation for lambrolizumab for treatment of patients with advanced melanoma, according to the drug’s manufacturer.
Lambrolizumab (MK-3475, Merck), an investigational antibody therapy that targets programmed death receptor (PD1), is being evaluated as treatment for patients with advanced melanoma and other tumor types.
The FDA grants breakthrough therapy designation to expedite the approval process of drugs used to treat life-threatening or serious diseases that may demonstrate substantial improvement over existing therapies.
Early results of a phase 1b study of lambrolizumab were presented in November at the International Congress of the Society for Melanoma Research.
The study included 85 patients with inoperable and metastatic melanoma. Fifty-one percent of patients showed objective anti-tumor response, including 9% who displayed complete response at or after 12 weeks.
Merck has initiated a global, randomized, phase 2 clinical trial to compare lambrolizumab with standard chemotherapy for patients with advanced melanoma who have not responded to previous therapy.
“The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone,” Gary Gilliland, MD, PhD, senior vice president and oncology franchise head for Merck Research Laboratories, said in a press release.