Incredibly, the Food and Drug Administration (FDA) has recently approved a new drug for breast cancer patients. On Friday, the FDA gave its approval for Novartis’s new breast cancer drug, which will expand the available options for patients in the more advanced stages of this deadly disease.
According to recent reports, the drug is known as Aflinitor, and it works by increasing the time in which endocrine therapy is able to keep this disease at bay. Now that it has been approved by the FDA, the drug can be used by the patients who are postmenopausal with a hormone receptor-positive form of the disease (this makes up a significant segment of the breast cancer patient population).
The usual treatment for these patients was aromatase inhibitors, which work by depriving the tumor of some of the essential fuels it uses to grow, the hormone estrogen. However, studies have shown that tumors can become resistant to these types of drugs. With the addition of the new Afinitor drug, the inhibitors appear to regain their effectiveness.
According to Dr. Melody Cobleigh, the director of the breast cancer program at Rush University Medical Center in Chicago, the results in recent breast cancer clinical studies have been very exciting to say the least. The tumor cells had somehow become resistant to the previous cancer treatment therapy, but now researchers have figured out a way to reverse that resistance.
According to recent reports, the final approval of Afinitor was based on the results of a recent trial conducted on about 724 participants with advanced stage breast cancer. These breast cancer patients had all been previously treated with either Femara (also a Novartis drug), or Arimidex (sold through AstraZeneca). The patients in this most recent clinical trial received fake medicine, Aromasin accompanied with a placebo, or a combination of Afinitor with Aromasin. All participants continued to receive treatment until either their cancer progressed, or they experienced severe side effects.
The main purpose of this study was to provide researchers with a way to measure the amount of time that a patient could live without their cancer getting worse. In the patients that were administered the Afinitor and Aromasin combination therapy, researchers recorded an average of 4.6 months before their cancer either progressed or they passed away. This was compared to the patients who received the Aromasin with a placebo.
According to the final report, the most common side effects experienced during the study were infections, mouth ulcers, rash, diarrhea, and a rash. The FDA has noted that any patients who are 65 and over will need to be monitored closely while taking this drug, because they are at a higher risk of experiencing more severe side effects.
The approval of this new breast cancer drug has made a big splash in the pharmaceutical industry. In fact, Afinitor is the first in the class of drugs known as mTOR inhibitors to receive approval from the FDA. These mTOR inhibitors are designed to treat postmenopausal women with advanced hormone-receptor positive breast cancer.
Additionally, the approval of Afinitor stands as proof of the value to be gained from continued research on drugs in other forms of cancer after they have been initially approved for the market. With its approval, Afinitor is now the first cancer treatment to improve the effectiveness of endocrine therapy in advanced stage breast cancer patients.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, was more than pleased to back up this drug’s approval in a recent press release. Hopefully, this decision will help to open the doors for continued testing of drugs that are already in use for a specific illness, in regards to additional diseases.