Perjeta might gain quick FDA approval
TUESDAY, Sept. 10, 2013 (HealthDay News) -- A drug already used to treat advanced breast cancer also appears to shrink early stage breast tumors, potentially offering women a first-of-its-kind treatment option, U.S. health regulators say.
If approved to treat early stage cancers, the drug, Perjeta, might result in less invasive surgical treatment for women with HER2-positive early stage breast cancer, Bloomberg News reported Tuesday.
In that role, Perjeta (pertuzumab) would be the first cancer-fighting drug approved as a neoadjuvant (first step) breast cancer therapy in the United States, the news agency said.
A U.S. Food and Drug Administration report posted online Tuesday by FDA staff members said the drug looks promising in trials. However, the report also said drug-related cardiac concerns will require additional research. A meeting is scheduled for Thursday to discuss the drug's merits.
Cancer specialists welcomed the news.
"This is tremendously exciting," said Dr. Amy Tiersten, associate professor in the division of hematology and medical oncology at Mount Sinai Medical Center in New York City.
"Pertuzumab was FDA approved in 2012 for the treatment of metastatic breast cancer [cancer that has spread to other parts of the body] when it was shown that it improved survival when added to standard regimens for HER2-positive metastatic breast cancer," Tiersten explained.
"But the really exciting information is when this can be translated into earlier stages of disease, where we can completely eradicate the disease and cure more women," said Tiersten.
The trial under discussion shows that when pertuzumab is added to standard pre-surgical regimens for HER2-positive breast cancer the chance of finding no cancer after this treatment is nearly doubled, Tiersten said.
Women who have chemotherapy before surgery and who achieve complete remission -- no cancer at the time of breast surgery -- have a much greater chance of being completely cured of their disease, she said.
Dr. Aye Moe Thu Ma, attending physician in breast surgical oncology with St. Luke's and Roosevelt Hospitals in New York City, also voiced enthusiasm.
"We currently have limited options for neoadjuvant treatment of breast cancer," she said. "I'm excited that this may provide a more specific treatment for people with HER2-positive cancer. Although survival advantage has not been documented for patients who received neoadjuvant therapy over adjuvant therapy, if neoadjuvant therapy is effective, more patients can have breast preservation surgery."
This means women can keep their breasts because the tumor size is reduced, and some women may prefer this, she said.
Roche's Genentech unit is hoping for accelerated approval of Perjeta. The FDA can expedite approval for groundbreaking drugs as long as the drug maker pursues more research to show that the medication prolongs disease-free survival.
Genentech estimates about 15,000 women with HER2-positive early stage breast cancer could receive early treatment with Perjeta each year, Bloomberg reported.
Both short- and long-term side effects will need to be examined to fully evaluate risks and benefits of this medication if it is approved, Ma added.
Pertuzumab is one of many newer biologic agents used to treat breast cancer. "These biologic or 'targeted' treatments work on breast cancer cells in a more specific way than some older treatments so that there are many fewer casualties to normal cells translating into many fewer side effects for our patients," Tiersten said.
It's a "win-win situation," Tiersten said.
About one in eight women in the United States will develop breast cancer in her lifetime.
According to the Mayo Clinic, HER2-positive breast cancer is a breast cancer driven by a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
HER2-positive breast cancers are typically more aggressive than other types of breast cancer. But there are effective drug treatments, including trastuzumab (Herceptin) and lapatinib (Tykerb). Both drugs can produce side effects, including congestive heart failure, the Mayo Clinic said.
The U.S. Department of Health and Human Services has more about early stage breast cancer (http://www.womenshealth.gov/publications/our-publications/fact-sheet/early-stage-breast-cancer.pdf ).
SOURCES: Amy Tiersten, M.D., associate professor, division of hematology and medical oncology, Mount Sinai Medical Center, New York City; Aye Moe Thu Ma, M.D., attending physician, breast surgical oncology, St. Luke's and Roosevelt Hospitals, New York City; Sept. 10, 2013, Bloomberg News