Merck & Co. announced Wednesday that the FDA granted breakthrough therapy status to the experimental drug lambrolizumab, also known as MK-3475, for the treatment of patients with advanced melanoma. Gary Gilliland, oncology franchise head in the company's research division, said the designation "opens up opportunities and lines of communication with the agency for creative ways to move development forward as quickly as possible." He suggested that one possible area of discussion is to determine whether there are ways to predict in advance which patients will respond well to the drug.
In an early-stage trial of the antibody therapy, which targets PD-1, results showed that about half of patients with advanced melanoma experienced tumour shrinkage after treatment with lambrolizumab and around 10 percent had no detectable cancer after treatment as assessed by imaging techniques. The drug is being investigated in a Phase II trial of patients with melanoma, and is also being studied in other cancer types including non-small-cell lung cancer. Analysts at Leerink Swann estimate that if approved, lambrolizumab could generate peak sales of $450 million in the melanoma indication by 2023.
FDA spokeswoman Sandy Walsh noted that "the concept behind 'breakthrough' is that, with increased communication, FDA will work with new drug developers to help design efficient ways to study the safety and effectiveness of their drug." The agency indicated that it has received 45 requests for breakthrough status designation, with 11 requests approved and 18 requests rejected. Other drugs granted breakthrough status include: Johnson & Johnson and Pharmacyclics' ibrutinib for mantle cell lymphoma and other cancers; Novartis' LDK378 for certain patients with non-small-cell lung cancer; and Pfizer's palbociclib for breast cancer.
Although analysts do not know how quickly the programme will deliver breakthroughs, ISI Group's Mark Schoenebaum said "it should be taken as a strong signal that the FDA will do everything to expedite approval of those drugs."
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