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AstraZeneca gets expanded FDA approval for cancer drug
  • By Marian Chu
  • Published 2018.01.15 10:20
  • Updated 2018.01.15 11:20
  • comments 0

The U.S. Food and Drug Administration said Friday it approved AstraZeneca’s PARP inhibitor Lynparza to treat patients with metastasized breast cancer with a specific inherited genetic mutation.

Lynparza won the FDA approval in 2014 as a first-in-class poly ADP-ribose polymerase (PARP) inhibitor to treat patients with a specific type of ovarian cancer.

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence and acting director of FDA’s Office of Hematology and Oncology Products.

This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of cancer, often across cancer types, he added.

Lynparza is now approved to treat germline breast cancer susceptibility gene (BRCA) mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer patients who have been previously treated with chemotherapy.

The National Cancer Institute estimates more than 250,000 women will be diagnosed with breast cancer this year and around 40,000 will die from the disease.

The FDA announcement marks the drug to be the first PARP inhibitor approved to treat breast cancer, the agency said, noting it is also the first approval for any drug to treat patients with metastatic breast cancer with a BRCA gene mutation.

Lynparza’s safety and efficacy were proven in a randomized clinical trial of 302 patients with HER2-negative metastatic breast cancer with a germline BRCA mutation. Data showed median progression-free survival for patients taking Lynparza to be seven months compared to 4.2 months for those receiving chemotherapy.

The agency said it also expanded the approval of BRACAnalysis CDx, a diagnostic test developed by Myriad Genetics, to include the detection of BRCA mutations in blood samples from patients with breast cancer.

yjc@docdocdoc.co.kr

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