Alpelisib got approval from the FDA to treat breast cancer when the tumours in patients have some genetic mutation. It is a targeted therapy called a PI3K inhibitor, particularly for advanced breast cancer patients.
Alpelisib is to be used with fulvestrant, which is hormone therapy. It is the first drug that received approval under the Real-Time Oncology Review pilot program of FDA. This program permits the drug manufacturers to begin the review procedure before the official submission of an application.
The FDA also granted the Priority Review designation to the application to accelerate the time, which is taken for drug review and approval.
The decision of the FDA based on the SOLAR-1 trial. In this study, 572 women and men were with HER2-negative, HR-positive, advanced breast cancer developed or spread during or after their treatment with an aromatase inhibitor. The results revealed improvement in progression-free survival for patients who had a PIK3CA mutation in their tumours and received Alpelisib and Fulvestrant. Patients with the mutation who received Alpelisib had an average progression-free survival of 11 months compared to the average of 5.7 months in patients who do not receive Alpelisib.
Alpelisib is a tablet formulated for oral route. Its common side effects were diarrhoea, rash, high blood sugar levels, fatigue, nausea and vomiting, decreased appetite, mouth sores etc. extremely severe skin reactions can occur. Patients should inform their doctor if they have a history of severe skin reactions before taking Alpelisib.
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Source: |
FDA |
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Link to the source: |
https://www.cancer.org/latest-news/fda-approves-first-pi3k-inhibitor-for-breast-cancer.html [Last accessed on: 19 January, 2021] |
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Original title of article: |
FDA Approves First PI3K Inhibitor for Breast Cancer |
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Translated by: |
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