Jan 12, 2018, 2:49 PM ET

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


U.S. regulators have approved the first drug aimed at women with advanced breast cancer caused by?an inherited flawed gene.

The Food and Drug Administration on Friday approved AstraZeneca PLC's Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy.

The drug has been on the market since 2014 for ovarian cancer, and is the first in a new class of medicines called PARP inhibitors to be approved for breast cancer. PARP inhibitors prevent cancer cells from fixing problems in their DNA.

Lynparza will cost $13,886 per month without insurance, according to AstraZeneca. The company is offering patients financial assistance.

"While there is currently no cure for metastatic breast cancer, today's approval offers a new, targeted option that may help to delay disease progression for these patients," Dr. Susan M. Domchek at the University of Pennsylvania's Abramson Cancer Center said in a statement.

Until recently, cancer medicines targeted the disease based on where in the body it occurs.

This is a new approach to "target the underlying genetic causes of a cancer," the FDA's Dr. Richard Pazdur said in a statement.

The agency also approved a companion blood test from Myriad Genetic Laboratories Inc. for detecting BRCA mutations and determining which patients likely would benefit from Lynparza.

About 250,000 people each year are diagnosed with breast cancer and just over 40,000 die from it, according to the National Cancer Institute. About 20 percent to 25 percent of patients with hereditary breast cancers have a BRCA mutation. BRCA-related breast cancer often strikes younger people and is harder to treat than other breast cancers.

The latest approval was based on a study of 302 women with cancers that have spread beyond the breast and who had a BRCA gene mutation.

Lynparza modestly delayed the time until cancer worsened — 7 months versus 4 months for women given one of three commonly used chemotherapies. About half the study participants responded to Lynparza compared with about a quarter of those only treated with chemotherapy. It's unknown whether treatment increases survival.

Possible side effects are less severe than for chemotherapy, but serious problems can include blood and bone marrow cancers. Common side effects include nausea, fatigue, respiratory infections and blood count problems.

Lynparza is marketed jointly by UK-based AstraZeneca and Merck & Co., which is based in Kenilworth, New Jersey.


Follow Linda A. Johnson on Twitter at @LindaJ—onPharma.

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

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  • Evan German

    I can just see the TV ads for this drug - ' If you have BRCA related cancer, we offer a chance to transform it into leukemia or other cancers. This is not a cure but a way to delay the onset of ??? and all for limited cost if you have good medical insurance'.

  • rightened

    "A study suggests that women diagnosed with early-stage breast cancer in one breast who are treated with lumpectomy followed by radiation therapy have the same survival rates as women who are treated with double mastectomy."

    Sorry, but if I had any inheritable breast cancer in my family, I wouldn't fight to "keep my femininity"--the breasts would come off, and I'd drop that cancer risk down dramatically, thanks. Even after mastectomies, there is still a tiny chance of developing cancer... but I'd rather risk that, and have it easier to find, than retain some ridiculous sentimentality to a body part that stands a good risk of killing me.

  • wd65

    Another case of a drug company using "your money or your life" pricing.
    Shame on AstraZeneca; $13,886 per month that doesn't cure the cancer, just delays it three month.
    I guess the 1% can afford it with their Trump tax cuts. And the CEO probably gets a $5 million bonus from it for sitting in his office.

  • Lilith Moon

    $13,000 and you might get some more cancer to go with your cancer? Yeah, that's super great.