A new immunotherapy drug has been granted approval by the U.S. Food and Drug Administration today. The drug is a cure for advanced melanoma, bringing a major shift in the pattern of the treatment of the deadly skin cancer disease.
The drug pembrolizumab was tested on more than 600 patients who had melanoma. Researchers found significant long-lasting responses on patients and eventually, FDA granted the drug “breakthrough therapy” status. Merck has planned to sell the drug under the brand name Keytruda. Keytruda is an antibody also known as MK-3475 and belongs to a modality known as immunotherapy.
Keytruda is a PD-1 inhibitor (programmed death receptor-1, a protein) drug. The drug comes in play by blocking a cellular pathway that interfere with the body’s immune system while attacking cancer cells.
It will soon start replacing surgery, radiation, chemotherapy, and other older cancer treatments.
Melanoma, a skin cancer originates in pigment-producing cells called melanocytes. The disease is particularly swift and deadly in cases where it transits to other sites in the body, particularly the brain. The deadly skin cancer, has gradually become more common with 76000 cases detected every year and resulting in death of around 10,000 Americans each year.
“Ninety percent of patients have basically no side effects,” said Dr. Antoni Ribas, a researcher and professor at UCLA’s Jonsson Comprehensive Cancer Center, lead investigator of a crucial study of Keytruda.
“This is a good day for melanoma patients and, potentially, for lots of other future cancer patients, too,” said Jim Allison, an M.D. Anderson Cancer Center immunologist who discovered a brake on the immune system that prevents it from attacking tumors, then translated the finding into a drug that unleashes the system. “This approval by the Food and Drug Administration shows it understands this class of drugs works and that they want to accelerate patients’ access to them.”
Allison’s drug, Yervoy (ipilimumab), has been accepted previously in the year 2012 for the advanced melanoma, following many years of trials.
The new drug “builds on Allison’s paradigm-shifting work” and represents the start of “a new era,” said Ribas.
Keytruda has been approved for those who did not respond to previous therapies and didn’t benefit from Yervoy, about 75 percent of those at the advanced stages of the disease.
Judith Gasson, senior associate dean for research at the David Geffen School of Medicine at UCLA and director of the Jonsson Cancer Center, said researchers have been awaiting very long to develop an effective and lasting immunotherapy to fight cancer.
The drug will cost $12,500 a month and Merck says the median usage is just over 6 months, which works out to a $77,500 price tag, or $150,000 for a year’s worth of treatment.
“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.”
Anti-PD-1 drugs are also showing positive results in trials involving at least 20 tumor types, including lung, bladder, head and neck, ovarian and gastric cancer.
“I owe my life to that drug. There’s no question about it,” Rich Murphy, 49, a real estate agent, said in an interview who was one of the study participant.
Tim Turnham, executive director of the Melanoma Research Foundation, said Keytruda’s approval is “a tremendous step forward for the melanoma patient community.”
“This is the most promising and positive patient response to a melanoma treatment to date,” he said in a statement, but cautioned that it won’t work in all late-stage melanoma patients – the goal of ongoing research.