FDA approves GlaxoSmithKline niraparib for treatment of terminal ovarian cancer
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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Today, the U.SFDA(http://announced that it has approved GlaxoSmithKline (GSK)company(http://niraparib(name Zejula) extended indications for the treatment of patients with advanced ovarian cancer who have undergone more than three types of chemotherapyAbout Niraparib
Niraparib is an important PARP inhibitor acquired by GSK after its $5.1 billion acquisition of TESARO last yearPARP inhibitors are(http://of anti-cancer
drugs developed using the principle of "
synthetic(http:// death" By inhibiting the PARP-mediated DNA damage repair mechanism, the accumulation of excessive DNA damage in tumors with BRCA gene mutations leads to the accumulation of excessive DNA damage, which leads to cell death This approval is based on the results of an open label called QUADRA, a single arm Phase 2 clinical trial (http:// The researchers found that Zejula not only had an effect in patients who carried the BRCA gene mutation (a total remission rate of 29%) and did not carry the BRCA gene mutation, but also in patients with homologous recombination defects (a total remission rate of 15%) In patients who did not carry brc a MUTATION in the BRCA gene and did not have homologous recombinant defects, Zejua achieved a total remission rate of 3%
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