A new and more effective treatment for women suffering from breast cancer may be available soon, after the phase III trial for Ibrance, a drug developed by Pfizer, has shown extremely positive results in delaying the need for chemotherapy. The overwhelmingly positive results have convinced Pfizer to stop the pivotal trials in April and move straight to phase III clinical trial on a group of 521 women suffering from advance stage breast cancer.
Combined Hormone Therapy Trials
In the clinical trials, the patients were treated with a combination of Ibrance and the Faslodex estrogen inhibitor by AstraZeneca (widely used currently in the traditional breast cancer treatment). The first trials have shown that the combination of these two drugs doubles the amount of time during which cancer can be controlled without chemotherapy treatment and also significantly decreases the likelihood of recurring breast cancer.
The findings of the trials were presented during the annual meeting of the American Society of Clinical Oncolgy (ASCO) in Chicago. Following the validation of the trial results, the US Food and Drug Administration has granted accelerated approval for the main ingredient of Ibrance, palbociclib.
Significant Results, Minimum Side Effects
Classic treatment with Faslodex would keep cancer at bay for approximately 4 months before beginning chemotherapy. By comparison, when Ibrance was added to the treatment scheme for the trial group, this period doubled, reaching 9 months. As lead study author, Nicholas C. Turner, team leader at the Cancer Research Institute in London, noted,
“This relatively easy-to-take new drug can substantially delay the point when women need to start chemotherapy, making this an exciting new approach for women.”
The only significant side effect observed during the trial was an irregularity in the blood count. However, this anomaly has a very low occurrence among the trial group, with only 2.6% of the participants interrupting the treatment due to infections.
How It Works
Palbociclib, the active ingredient of Ibrance, acts as an inhibitor of two enzymes, cyclin-dependent kinase 4 and 6, which are responsible with cell growth. These types of enzymes are responsible for the occurrence of 75% of the different variations of breast cancers worldwide. In combination with the effect of Faslodex, which inhibits the estrogen feminine hormone, the cancer cells are prevented from developing and spreading throughout the breast tissue.
If this new drug is approved for manufacturing and distribution, it is predicted to generate sales amounting to $5 billion per year.
Image Source: Ibrance capsules
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