AstraZeneca's Lynparza becomes first U.S.-approved PARP inhibitor for breast cancer with BRCA gene mutation

Country : U.S.

Keywords :
LONDON, Jan 12 (APM) - AstraZeneca's Lynparza has been approved in the U.S. for expanded use to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene, it was announced on Friday.
The U.S. Food and Drug Administration said in a statement that it is the first PARP inhibitor approved to treat breast cancer, and the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation.
The drug belongs to a class of drug known as PARP inhibitors that has already been used to treat advanced BRCA-mutated ovarian cancer, the FDA said.
Patients are selected for treatment with Lynparza (olaparib) based on an FDA-approved genetic test called BRACAnalysis CDx.
Director of the FDA's Oncology Centre of Excellence Dr Richard Pazdur said: “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. This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”
Approximately 20-25% of patients with hereditary breast cancer and 5-10% of patients with any type of breast cancer have a BRCA mutation. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumour development. However, mutations of these genes may lead to certain cancers, including breast cancer.
Lynparza is a PARP (poly ADP-ribose polymerase) inhibitor that blocks an enzyme involved in repairing damaged DNA.
Lynparza was first approved by the FDA in 2014 to treat certain patients with advanced, pretreated, BRCA-mutated ovarian cancer. In 2017 a tablet formulation was authorised as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who are in response to platinum-based chemotherapy, regardless of BRCA status.
It is now also indicated for patients with germline breast cancer susceptibility gene (BRCA) mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been previously treated with chemotherapy.
Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior hormonal (endocrine) therapy or be considered inappropriate for endocrine treatment, the FDA said.
The FDA has also expanded the approval of BRACAnalysis CDx, an approved companion diagnostic to Lynparza, to include the detection of BRCA mutations in blood samples from patients with breast cancer.
Lynparza is approved in Europe in advanced ovarian cancer.



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.