Gilead Cell-Therapy Drug Yescarta Gets FDA Approval -- Update
October 18 2017 - 7:19PM
Dow Jones News
By Jonathan D. Rockoff
Gilead Sciences Inc.'s $11 billion bet on buying Kite Pharma
Inc. is poised to pay off, with the approval Wednesday of Kite's
flagship cell-therapy treatment for adults with advanced
lymphoma.
The therapy, known as a Car-T treatment, uses genetically
engineered T-cells to attack the blood cancer. It is the second
such therapy to get a regulatory green light, after Novartis AG's
Car-T drug Kymriah was approved in late August for a form of
leukemia in children and young adults.
Like Novartis's therapy, which was priced at $475,000, Gilead's
treatment commands a six-figure list price: $373,000.
Gilead Chief Executive John Milligan said in a statement that
the approval marks "an important day for patients with relapsed or
refractory large B-cell lymphoma who have run out of options and
have been waiting for new treatments that may help them in their
fight against cancer."
The newly approved therapy, dubbed Yescarta, was the crown jewel
of Gilead's recent purchase of biotech Kite Pharma. It has been
among the most highly anticipated new drugs on Wall Street, which
estimates the therapy will have $1.7 billion in world-wide sales in
five years, according to EvaluatePharma, a market-research
firm.
Sales of Yescarta should bolster Gilead's efforts to diversify
beyond its legacy drugs for HIV/AIDS and hepatitis C as their sales
slow.
The company, which was criticized by patients, doctors and
lawmakers for the high list price of hepatitis C treatment Sovaldi,
could face a new round of scrutiny over Yescarta's price tag. A
Gilead spokeswoman pointed to clinical-trial data showing the drug
worked in far more patients than current standard-of-care
treatment.
"Taking into account these important clinical data, we conducted
extensive research with commercial and government payers, as well
as targeted cancer centers, to set a price that reflects the value
represented by this innovation, and that supports accessibility of
this personalized therapy," the Gilead spokeswoman said.
The Food and Drug Administration approved Yescarta for adults
with certain advanced forms of diffuse large B-cell lymphoma, the
most common type of non-Hodgkin lymphoma in adults. Gilead said
about 7,500 patients in the U.S. will be eligible each year for
treatment.
Cell therapies such as Yescarta are part of a broader wave of
immunotherapies that harness the body's immune system to attack
cancer, providing a new option for certain cancer patients whose
disease has proven hard to treat.
The new treatments have "gone from being a promising concept to
a practical solution to deadly and largely untreatable forms of
cancer," FDA Commissioner Scott Gottlieb said in a statement.
Yescarta is made from a patient's own immune cells, called T
cells, which are taken from the patient and sent to a laboratory
where they are genetically engineered to attack cancer. The
modified T cells are put back into the patient where they are able
to recognize and attach to a particular protein on tumor cells,
killing them. The new feature that gives the engineered T cells
their cancer-fighting powers is called a chimeric antigen receptor,
hence the name Car-T therapy.
In the pivotal clinical trial of Yescarta, tumors shrank in 72%
of the 101 subjects and disappeared in 51% of the patients,
according to Gilead.
Side effects reported in the trial included fever, anemia and
low white-blood cell counts, which can increase vulnerability to
infection. The deaths of two subjects were determined to be related
to the drug's use.
Yescarta will have a Black Box warning regarding the risk of
"life-threatening" high fever and flulike symptoms during
treatment, and use will be limited to specially certified hospitals
and cancer clinics following risk-mitigation guidelines for safe
use, according to the FDA announcement.
Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
(END) Dow Jones Newswires
October 18, 2017 19:04 ET (23:04 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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