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Rucaparib—new drug for Ovarian cancer—received priority assessment eligibility from FDA

2016-08-29 来源:亚科官网
29 August 2016
 
  Ovarian malignancy is one of the common malignant tumors of female genitalia, the incidence rate is only after cervical cancer and uterine cancer. And according to the American Cancer Society, there will be 22,000 women diagnosed with ovarian cancer in 2016 in US. Clovis Oncology recently issued a statement announcing that the FDA has accepted an application for accelerated approval of its new ovarian cancer clinical drug Rucaparib and has given it priority in accreditation. The results of the review will be given by the end of February 2017. While the European Medicines Agency's listing application is scheduled to be completed in the fourth quarter of 2016.
 
  Recurrent ovarian cancer has been very difficult to cure, especially those with BRCA gene. Although there are already treatment options, but the effect is still limited. Therefore, the use of Rucaparib to treat patients with BRCA mutations and who have received at least two chemotherapy regimens has a great significance.
 
  Rucaparib is an ongoing oral small molecule drug for advanced ovarian cancer and is an inhibitor of the three enzymes of PARP1, PARP2 and PARP3. It plays a role by inhibiting polyadenyl diphosphate ribose polymerase (PARPs), which can hinder the occurrence of certain gene mutations that can spread cancer in the body. It is currently in the second phase of clinical, and has been recognized as breakthrough drug by the US FDA in April last year.
 
Rucaparib 结构图
 
  Patrick J. Mahaffy, president and CEO of Clovis Oncology, said: "The FDA's application for new drugs, whether for Rucaparib or Clovis, is an important milestone, patients with BRCA ovarian cancer genes require more treatment methods. We look forward to working with FDA on new drug review. "
 
  Although AstraZeneca's Lynparza will announce the latest research data and is expected to be fully approved by FDA, but to Patrick, it seems to have been difficult to shake the advantages of rucaparib. FDA's move is undoubtedly selected Rucaparib, affected by this news, even Clovis's stock also rose about 10%.
 
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Edited by Suzhou Yacoo Science Co., Ltd.