The U.S. Food and Drug Administration approves Ripretinib tablets as the first new drug as a fourth-line therapy for treating the advanced gastrointestinal stromal tumour (GIST). GIST is a type of tumour, which begins in the gastrointestinal tract.
Ripretinib is indicated for the patients (adults) who were previously treated with three or more kinase inhibitor treatments. It is a kinase inhibitor, which acts by inhibiting the enzyme called a kinase that assists the cancer cells growth.
The approval of Ripretinib was based on the outcomes of a clinical trial including one hundred and twenty-nine patients suffering from advanced GIST who had taken earlier therapy with other FDA-approved targeted treatments, regorafenib, imatinib and sunitinib.
The comparison was made between the patients who received Ripretinib to patients who received placebo to assess if the progression free survival (PFS) was more prolonged in the Ripretinib group in comparison to the placebo group. During therapy in the trial, Ripretinib or placebo was administered by the patients only one time day in 28-day cycles, which was repeated till tumour growth was seen or the patient suffered intolerable side effects. Following disease progression, the patients of the placebo group were provided with the choice to switch to Ripretinib.
The PFS rate in Ripretinib group patients was 6.3 months (on an average). On the other side, the PFS rate was one month in the placebo group patients.
The FDA granted it Priority Review and Fast Track designation and Breakthrough Therapy designation that speed ups the development and review of drugs, which are meant for the treatment of the severe condition.
Ripretinib also received Orphan Drug designation that grants incentives to help and support the drug development for rare diseases.
|Link to the source:||https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-fourth-line-treatment-advanced-gastrointestinal-stromal-tumors
[Last accessed on: 10 December, 2020]
|Original title of article:||FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors|