Guide
Breast cancer is one of the most common causes of death in women with cancer, with approximately 20%-25% of hereditary breast cancer patients and 5%-10% of any type of breast cancer patients having BRCA mutations. On January 12, the US FDA announced the approval of AstraZeneca's Lynparza for new indications for BRCA-mutant HER2-metastatic breast cancer patients.
Lynparza (olaparib) is an oral poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca that uses tumor DNA damage response (DDR) pathway defects to kill cancer cells.
The FDA's approval is based on a trial that estimates the safety and efficacy of approximately 300 patients with HER2-negative, BRCA-mutated metastatic breast cancer who underwent Lynparza or chemotherapy. The median PFS was 7 months in the Lynparza group and 4.2 months in patients receiving chemotherapy.
It is worth mentioning that Lynparza is not only the first PARP inhibitor approved for breast cancer, but also the first PARP inhibitor for the treatment of breast cancer patients with BRCA mutations.
Richard Pazdur, director of the FDA's Center for Excellence in Cancer, said in a statement: "These drugs have been used to treat advanced BRCA-mutated ovarian cancer and have now shown efficacy in treating certain types of BRCA-mutant breast cancer. Proof of the current development of drugs for the underlying genetic causes of cancer, often spanning multiple cancer types."
There are currently three PARP inhibitors in the world, including Lybrari (Rucaparib) from Clovis Oncology and Zejula (niraparib) from Tesaro.
From the sales in the third quarter of 2017, Lynparza (olaparib) had sales of $81 million from July to September 2017, net income from Clovis Oncology's Rubraca (rucaparib) and Tesaro's Zejula (niraparib). AstraZeneca still occupied a favorable position with $16.8 million and $39.4 million, respectively.
In addition, the FDA has also approved Myriad Genetics' BRACAnalysis CDx, which identifies BRCA mutations in blood samples from breast cancer patients for screening patients eligible for Lynparza treatment.
The FDA's approval to expand the indications also proves that AstraZeneca's big investment in Lynparza is worthwhile. We hope that Lynparza will go well and benefit more patients.
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