US OKs 1st drug aimed at women with inherited breast cancer

According to the paper, this is the largest study of its kind to look at breast cancer outcomes based on a woman's BRCA mutation status.

Having a mutated BRCA gene - as famously carried by - dramatically increases the chance a woman will develop breast cancer in her lifetime, from 12 per cent to 90 per cent.

Lynparza is produced by the British drug maker AstraZeneca, whose US headquarters are in Wilmington, Del.

The FDA approved its PARP inhibitor Lynparza for metastatic breast cancer, offering the pharma giant a path forward to expand its use beyond ovarian cancer.

Lynparza belongs to a class of drugs called PARP inhibitors that block an enzyme involved in repairing damaged DNA.

'This is excellent news for women with this uncommon but important genetic form of breast cancer, many of whom took part in the clinical trials'.

One study surveyed 487 women after they underwent either a lumpectomy that removes malignant tissue while sparing the rest of the breast, a mastectomy that removes the entire breast, or both procedures. Half had breast-conserving surgery, half had a full mastectomy and less than 1 per cent had no breast surgery. They had been diagnosed with breast cancer between 2000 and 2008.

The findings come amid a slew of research in recent months into the gene, which could make BRCA-related cancer more manageable, and treatment or preventative measures less invasive. Patients who took the drug had an average seven months of progression-free survival, compared to 4.2 months among patients who were given only chemotherapy.

Possible side effects are less severe than for chemo, but can include serious ones such as blood and bone marrow cancers. Because Lynparza can harm a developing fetus, women are advised to use contraception while on the drug. For women with a mutation whose breast tumors were also triple-negative-which refers to the lack of three specific characteristics seen in a breast tumor-their odds of long-term survival was the same, too.

The EndPoints biophara website stated reported that the FDA OK marked a victory for AstraZeneca CEO Pascal Soriot and a decision to focus on cancer drugs.

AstraZeneca said this is the third indication approved for Lynparza in the USA, where it has been used to treat almost 4,000 advanced ovarian cancer patients.

The study's author, Professor Diana Eccles, of the University of Southampton, said: "Women diagnosed with early breast cancer who carry a BRCA mutation are often offered double mastectomies soon after their diagnosis or chemotherapy treatment".

Martin Ledwick, Cancer Research UK's head information nurse, said: 'Although BRCA faults increase the risk of young women developing cancer, their outlook once diagnosed is no worse than that for young women with breast cancer who don't carry the BRCA gene faults'. The drug was linked with tumor shrinkage in 60% of the patients with germline BRCA1 or BRCA2 mutations taking the drug, compared to 29% in the chemo group.

Vanessa Coleman

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