Great news for all the breast cancer heroines: the U.S. Food and Drug Administration (FDA) has approved the first neodjuvant drug for treatment of early-stage breast cancer. Rocher’s Perjeta (pertuzumab) was selected as part of a complete therapy regimen to treat early-stage, metastatic HER2-positive breast cancer. HER2 is a certain protein that is present in only 20% of breast cancer patients. Perjeta only targets that protein and works in its sole presence.
Neoadjuvant therapy is the administration of a therapeutic agent before the main therapy (chemotherapy.) This is the first drug that the FDA has selected as part of the neoadjuvant setting, whereas in the past the only neoadjuvant choice of treatment was surgical removal of the tumor. The Perjeta selection is a landmark discovery. Doctors hope that Perjeta will help in shrinking tumor size and prevent the spread of cancer to other body parts. They are optimistic also that Perjeta will help in reducing full mastectomy rates, although there are no current studies to prove these expectations.
“By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences,” said Dr. Richard Pazdur, director of the FDA office of cancer products.
The green light that FDA granted Perjeta is called an accelerated approval. Accelerated approval is only given to drugs that show groundbreaking results when used for treating life-threatening diseases in early studies. Accelerated approval was granted to Perjeta after Rocher (Genetech Unit) conducted a study designed to measure the complete absence of invasive cancer in breast and lymph nodes known as pathologic complete response (pCR). The study involved 417 female participants who received Perjeta combined with Herceptin, another Genetech drug, and standard chemotherapy. The result showed that 39% of the women reached pCR with Perjeta added to the treatment regimen while only 21% reached pCR with Herceptin and chemotherapy alone. After initial approval, Roche must conduct a larger follow-up study (using 1,00+ subjects) to determine long-term benefits of Perjeta for patients, meaning higher quality of life and longevity of life. The course of treatment for the Herceptin/Perjeta combination is estimated to take from nine to 18 weeks.
Now with the new Perjeta discovery, one can hope for more neoadjuvant drugs being discovered for breast cancer treatment. Additionally, ongoing research provides new discoveries on a consistent basis. There is plenty for breast cancer survivors and their friends and families to be hopeful about. Because of the efforts of doctors, scientistis and non-profit foundations, much more attention has been paid to this disease within the last several years. As science progresses, so too will new treatment options become available for women and men suffering from breast cancer. Let’s hope the “gods” of the high-profile medicine companies cook more medications for the FDA to approve and grant the green light to. As we wait, let’s send a shout out to every woman who lost the battle to breast cancer: You will not be forgotten!
Written by: Jaylan Salah