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FDA Approves Olaparib for Breast Cancer With a BRCA Gene Mutation

14 January 2018
FDA Approves Olaparib for Breast Cancer With a BRCA Gene Mutation

"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 the FDA's Oncology Center of Excellence.

In a commentary accompanying the study, Peter Fasching, from Friedrich-Alexander University Erlangen-Nuremberg in Germany, wrote: "Understanding prognosis in young patients is important because patients with BRCA mutations are at increased risk of developing specific conditions, such as secondary cancers".

U.S. regulators have approved the first drug to treat women with advanced breast cancers caused by the same flawed gene that Angelina Jolie made famous.

Their Phase III data made the showcase round at ASCO last summer and is further enhancing the FDA's focus on drugs that can target cancers triggered by the same genetic causes.

During this time, 651 of the women died from breast cancer, and those with the BRCA mutation were equally likely to have survived at the two-, five- and 10-year mark as those without the genetic mutation.

In 2013, Hollywood star Angelina Jolie announced she had had both breasts surgically removed as a preventative measure after tests revealed she carried the mutation, despite not having been diagnosed with cancer. Lynparza has the broadest clinical development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to deliver Lynparza as quickly as possible to more patients across multiple settings, including breast, ovarian, prostate and pancreatic cancers.

According to the American Cancer Society, women with a mutation in the BRCA1 or BRCA2 genes have a seven-in-10 chance of getting breast cancer by the age of 80.

For the new study, Eccles and a team recruited 2,733 British women aged 18-40 who had been diagnosed with breast cancer between 2000 and 2008.

About 12 percent of the patients had a BRCA mutation, yet again confirming the association between this "faulty gene" and breast cancer. In the trial, olaparib significantly prolonged progression-free survival (PFS) compared with chemotherapy, and reduced the risk of disease progression or death by 42% (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.43-0.80; P = 0.0009).

Common side effects of Lynparza include low levels of red blood cells (anemia), low levels of certain white blood cells (neutropenia, leukopenia), nausea, fatigue, vomiting, common cold (nasopharyngitis), respiratory tract infection, influenza, diarrhea, joint pain (arthralgia/myalgia), unusual taste sensation (dysgeusia), headache, indigestion (dyspepsia), decreased appetite, constipation and inflammation and sores in the mouth (stomatitis).

"Our study is the largest of its kind, and our findings suggest that younger women with breast cancer who have a BRCA mutation have similar survival to women who do not carry the mutation after receiving treatment", said lead researcher Diana Eccles.

The U.S. Food and Drug Administration has approved a new indication for olaparib tablets (Lynparza).