FDA Approves First Drug for Tumors Tied to Breast Cancer Genes

From Drugs.com - January 12, 2018

FDA Approves Lynparza (Olaparib), First Drug for Tumors Tied to Breast Cancer Genes

FRIDAY, Jan. 12, 2018 -- The U.S. Food and Drug Administration on Friday approved the first drug aimed at treating metastatic breast cancers linked to the BRCA gene mutation.

These mutated genes, called BRCA1 and BRCA2, first came to prominence in 2013 when actress and director Angelina Jolie announced she'd undergone a preventive double mastectomy. Jolie said she carried the BRCA1 gene, which greatly raises a woman's odds for breast and ovarian cancers.

Now, the FDA says it is expanding approval of Lynparza (olaparib) to include use against BRCA-linked tumors that have spread beyond the breast.

Lynparza is one of a group of powerful new cancer drugs known as PARP inhibitors, and it's the first such drug to be approved for use against breast cancer, the FDA noted. Lynparza is already approved to treat certain ovarian cancers.

PARP inhibitors have already "been used to treat advanced, BRCA-mutated ovarian cancer and have now shown efficacy in treating certain types of BRCA-mutated breast cancer," Dr. Richard Pazdur, who directs the FDA's Oncology Center of Excellence, explained in an agency news release.

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

According to the FDA, BRCA mutations are involved in up to one in every four breast cancers that are thought to have a hereditary component. These aberrant genes are also implicated in between 5 and 10 percent of non-hereditary breast tumors, the agency said.

When it's functioning properly, BRCA actually helps repair damaged cellular DNA and prevent tumors, but when BRCA1 and BRCA2 go awry they instead encourage breast cancers.

PARP inhibitor medicines such as Lynparza appear to interfere with the function of mutated BRCA with breast cells, causing them to die rather replicate -- slowing tumor growth, the FDA explained.

The safety and effectiveness of Lynparza for women with advanced BRCA-linked breast cancers was established after a trial of more than 300 patients.

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