On
June 8, 2012, the U.S. Food and Drug Administration approved Perjeta
(pertuzumab), a new anti-HER2 therapy, to treat patients with
HER2-positive late-stage (metastatic) breast cancer.
Intended
for patients who have not received prior treatment for metastatic
breast cancer with an anti-HER2 therapy or chemotherapy, Perjeta is
combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a
type of chemotherapy.
HER2
is a protein involved in normal cell growth. It is found in increased
amounts on some types of cancer cells (HER2-positive), including some
breast cancers. In these HER2-positive breast cancers, the increased
amount of the HER2 protein contributes to cancer cell growth and
survival.
Perjeta
is a humanized monoclonal antibody, manufactured through biotechnology
methods. It is administered intravenously and is believed to work by
targeting a different part of the HER-protein than trastuzumab,
resulting in further reduction in growth and survival of HER2-positive
breast cancer cells.
Because
there are production issues that potentially could affect the long-term
supply of the drug, FDA limited its approval today to drug product that
has not been affected by those issues. Genentech, the manufacturer of
Perjeta, has committed to take steps designed to resolve these
production issues in a timely manner.
“Given
the need for additional treatments for metastatic breast cancer, we
made the decision to approve this drug today and not to delay its
availability to patients pending resolution of the production issues
relating to future supply,” said Janet Woodcock, M.D., director of FDA’s
Center for Drug Evaluation and Research. “Genentech is currently
developing a plan to mitigate the effect on patients of any potential
shortage of Perjeta.”
Breast
cancer is the second leading cause of cancer-related death among
women. This year an estimated 226,870 women will be diagnosed with
breast cancer, and 39,510 will die from the disease. About 20 percent of
breast cancers have increased amounts of the HER2 protein.
“Since
trastuzumab was first approved more than a decade ago, continued
research has allowed us to better understand the role HER2 plays in
breast cancer,” said Richard Pazdur, M.D., director of the Office of
Hematology and Oncology Products in the FDA’s Center for Drug Evaluation
and Research. “This research provided the background to combine two
targeted drugs – trastuzumab and Perjeta with docetaxel to slow disease
progression in breast cancer.”
The
safety and effectiveness of Perjeta were evaluated in a single clinical
trial involving 808 patients with HER2-positive metastatic breast
cancer who were tested prior to treatment to determine if the HER2
protein was increased. Patients were randomly assigned to receive
Perjeta, trastuzumab and docetaxel or trastuzumab and docetaxel with a
placebo.
The
study was designed to measure the length of time a patient lived
without the cancer progressing, progression-free survival (PFS). Those
treated with the combination containing Perjeta had a median PFS of 18.5
months, while those treated with the combination containing placebo had
a median PFS of 12.4.
The
most common side effects observed in patients receiving Perjeta in
combination with trastuzumab and docetaxel were diarrhea, hair loss, a
decrease in infection-fighting white blood cells, nausea, fatigue, rash,
and nerve damage (peripheral sensory neuropathy).
Perjeta
is being approved with a Boxed Warning alerting patients and health
care professionals to the potential risk of death or severe effects to a
fetus. Pregnancy status must be verified prior to the start of Perjeta
treatment.
The
therapy was reviewed under the agency’s priority review program, which
provides for an expedited six-month review of drugs that may offer major
advances in treatment.
Perjeta is marketed by South San Francisco-based Genentech, a member of the Roche Group.
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