FDA Approves First Drug for Tumors Tied to Breast Cancer Genes

Gladys Abbott
January 14, 2018

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.

BRCA carriers with triple-negative breast cancer, however, may have a survival advantage over those without the mutation in the first few years after diagnosis, reported Diana M. Eccles, MD, of the University of Southampton School of Medicine, and colleagues in The Lancet Oncology.

Clovis' PARP inhibitor Rubraca (rucaparib) was approved in the U.S.in late 2016 for advanced ovarian cancer patients who have received at least two prior lines of chemo and whose tumors harbor the BRCA mutation.

On Thursday, research led by the University of Southampton concluded that BRCA-mutated breast cancer is no more unsafe or aggressive than any other form of the disease. 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.

The study found that there was no difference in overall survival two, five or 10 years after diagnosis for women with or without a BRCA mutation.

The survival rates for both BRCA carriers and non-carriers were similar: after 2 years, the survival rates were 97% for carriers and 96.6% for non-carriers. Half had breast-conserving surgery (49%), half had a mastectomy (50%), and less than 1% had no breast surgery.

BRCA mutations can cause cancer because the DNA self-repair mechanisms can malfunction.

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"In particular, being able to give some women with triple negative breast cancer the choice to delay a risk-reducing mastectomy would allow them to take back control of a major part of their treatment and offer them more time to recover from their initial therapy".

It is estimated that approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease, according to the FDA.

"The trial measured the length of time the tumors did not have significant growth after treatment [progression-free survival]", the agency explained.

Lynparza's most common side effects included anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, cold-like symptoms, and respiratory tract infections.

Dr. Susan M. Domchek, Executive Director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania and a national leader on the OlympiAD trials, said: "Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and hard to treat".

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

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