July 20 The U.S. Food and Drug Administration on
Friday approved Novartis AG drug Afinitor to treat
women with a certain type of breast cancer.
The drug is the first in a class known as mTOR inhibitors to
be approved for post-menopausal women with advanced
hormone-receptor positive, HER2-negative breast cancer. The
European Medicines Agency in June also endorsed Afinitor as a
breast cancer treatment.
Afinitor, also known as everolimus, is designed to be given
in combination with another drug, Aromasin, to treat women whose
cancer has recurred or progressed after treatment with two other
therapies. Aromasin is made by Pfizer Inc.
Novartis's drug - expected to become a major seller for the
Swiss drugmaker - is already approved to treat patients with
four other types of cancer, including kidney and a rare type of
"Afinitor is another example of the value of continuing to
study drugs in additional types of cancer after their initial
approval," said Dr. Richard Pazdur, head of the FDA's cancer
Breast cancer is the second leading cause of cancer-related
death among women, after lung cancer. This year, an estimated
226,870 women will be diagnosed with breast cancer - about
40,000 of them with advanced breast cancer - and 39,510 will die
from the disease.
A late-stage trial of 724 women showed those who received
Afinitor plus Aromasin on average had 7.8 months before their
cancer worsened, a 4.6 month improvement over people getting
just Aromasin plus a placebo, the FDA said.
Cancer is an increasingly important therapeutic area for
Novartis, which faces stiff competition in the field from
cross-town rival Roche Holding AG, the world leader in
"This approval redefines the treatment and management of
advanced hormone receptor-positive breast cancer, offering a
critical new option for physicians and patients," said the
co-lead investigator for the main Afinitor trial, Dr. Gabriel
Hortobagyi, who is also a consultant for Novartis and chairman
of Breast Medical Oncology at the University of Texas MD
Anderson Cancer Center.