FDA Gives Approval to First Drug for Treatment of Inherited Breast Cancer

The U.S. Food and Drug Administration has approved the first drug that is aimed at treating women who have advanced breast cancer that is caused by a flawed inherited gene.

The FDA in Friday announced its approval of AstraZeneca’s Lynparza for cancer patients that have BRCA gene mutations and have already undergone chemotherapy.

This drug has been available since 2014 for treatment of ovarian cancer, and is the first of a new class of treatments known as PARP inhibitors to be given approval to treat breast cancer. The PARP inhibitors help to prevent cancer cells from correcting problems in their own DNA.

Lynparza will have a monthly cost of $13,886 without insurance, said a representative from AstraZeneca. The pharmaceutical giant will be offering financial assistance to patients.

While currently there is not a cure for metastatic breast cancer, the approval on Friday offers a targeted option that might help delay the progression of the disease in patients with this gene, said a doctor that specializes in cancer treatments.

Until just recently, medicines for cancer targeted the disease based upon where it occurred in the body. The new approach targets underlying genetic causes for cancer, said Dr. Richard Pazdur with the FDA in a prepared statement.

The federal regulatory agency also gave its approval to companion blood test that was developed by Myriad Genetic Laboratories Inc. that detects BRCA mutations and determines which cancer patients would likely benefit from taking Lynparza.

Approximately 250,000 people annually are given a diagnosis of breast cancer, and slightly more than 40,000 will die, according to data released by the National Cancer Institute.

Between 20% and 25% of the patients diagnosed with hereditary breast cancer carry a BRCA mutation. The breast cancer related to BRCA often is developed by younger people and it is harder to treat than most breast cancers.

Friday’s approval was based in part on a study that included 302 women with cancer that spread beyond the breast and carried a BRCA gene mutation.

The time until there was a worsening of the cancer in those taking Lynparza was seven months versus four months for those women who received just one of the three chemotherapies commonly used.

Approximately 50% of the participants in the study responded to using Lynparza, in comparison to only 25% of those treated only with chemotherapy. It is not known if the treatment has any impact on increasing survival.

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