The FDA gave accelerated approval to rucaparib for
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Posted On: 03/07/2017 10:21:54 PM
The FDA gave accelerated approval to rucaparib for ovarian cancer last month. Just 106 paients were required. The primary endpoint was complete or partial shrinkage of their tumors, which the K-OC trial will be measuring by RECIST version 1.1 as a secondary endpoint.
"The safety and efficacy of rucaparib were studied in two, single-arm clinical trials involving 106 participants with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. BRCA gene mutations were confirmed in 96 percent of tested trial participants with available tumor tissue using the companion diagnostic. The trials measured the percentage of participants who experienced complete or partial shrinkage of their tumors. Fifty-four percent of the participants who received rucaparib in the trials experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months."
https://reachmd.com/news/new-treatment-for-ad...d/1438503/
"The safety and efficacy of rucaparib were studied in two, single-arm clinical trials involving 106 participants with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. BRCA gene mutations were confirmed in 96 percent of tested trial participants with available tumor tissue using the companion diagnostic. The trials measured the percentage of participants who experienced complete or partial shrinkage of their tumors. Fifty-four percent of the participants who received rucaparib in the trials experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months."
https://reachmd.com/news/new-treatment-for-ad...d/1438503/
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