FDA approves first drug for tumors tied to breast cancer genes

January 12, 2018

(HealthDay)—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 and .

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 drugs known as PARP inhibitors, and it's the first such 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.

"The trial measured the length of time the tumors did not have significant growth after treatment [progression-free survival]," the agency explained. "The median progression-free survival for patients taking Lynparza was 7 months compared to 4.2 months for patients taking chemotherapy only."

Lynparza does come with side effects, which can include anemia, low white blood cell counts, nausea, fatigue, vomiting, headache, joint pain, increased susceptibility to colds and other respiratory tract infections, and other effects. Because Lynparza can harm a developing fetus, women are advised to use contraception while on the drug. Women should also not breast-feed while using Lynparza, the FDA said.

The drug is made by AstraZeneca.

Along with the expanded approval of Lynparza, the FDA said it has "also expanded the approval of the BRACAnalysis CDx, an approved companion diagnostic to Lynparza, to include the detection of BRCA mutations in blood samples from patients with breast cancer."

In related news, a study published Jan. 11 in The Lancet Oncology found that young patients who carry a BRCA mutation do not have shorter survival when compared to patients without the mutation.

The study, which followed more than 2,700 for 10 years, was led by Diana Eccles from the University of Southampton in England.

Explore further: Breast cancer gene does not boost risk of death: study

More information: Find out more about BRCA1 and BRCA2 at the U.S. National Cancer Institute.

Related Stories

Breast cancer gene does not boost risk of death: study

January 12, 2018
Young women with the BRCA gene mutation that prompted actress Angelina Jolie's pre-emptive and much-publicised double mastectomy are not more likely to die after a breast cancer diagnosis, scientists said Friday.

PARP inhibitor improves progression-free survival in patients with advanced breast cancers and BRCA

December 8, 2017
In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, the PARP inhibitor talazoparib extended progression-free survival (PFS) and improved quality-of-life measures over ...

Drug helps fight breast tumors tied to 'cancer genes'

June 4, 2017
A twice-daily pill could help some advanced breast cancer patients avoid or delay follow-up sessions of chemotherapy, a new clinical trial reports.

PARP inhibitor may be effective against some TNBC lacking BRCA mutations

November 1, 2017
The investigational PARP inhibitor talazoparib caused regression of patient-derived xenografts (PDXs) of triple-negative breast cancers (TNBC) that had BRCA mutations and also those that did not have BRCA mutations but had ...

Olaparib slows growth of BRCA-related metastatic breast cancer

June 5, 2017
Findings from a phase III clinical trial of about 300 women may introduce PARP inhibitors as a new type of treatment for breast cancer. Compared to standard chemotherapy, the oral targeted medicine olaparib (Lynparza) reduced ...

Drugs score big wins against lung, prostate, breast cancers

June 5, 2017
Drugs are scoring big wins against common cancers, setting new standards for how to treat many prostate, breast and lung tumors. There's even a "uni-drug" that may fight many forms of the disease.

Recommended for you

Study finds melanoma biomarkers predicting checkpoint blocker response

July 18, 2018
Scientists at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) have identified biomarkers in melanoma that could help tailor immunotherapy treatments to maximize the benefits for patients while reducing the likelihood ...

Link found between bitter-taste sensitivity and cancer risk

July 18, 2018
High bitter-taste sensitivity is associated with a significantly increased risk of cancer in older British women, according to researchers who conducted a unique study of 5,500 women whose diet, lifestyle and health has been ...

Scientists discover a mechanism of drug resistance in breast and ovarian cancer

July 18, 2018
There is a highly sophisticated way to treat some breast and ovarian cancers—a class of drugs called PARP inhibitors, designed to exploit the very defects that make tumors with certain mutations especially deadly. Yet this ...

Research identifies new breast cancer therapeutic target

July 18, 2018
Research led by Suresh Alahari, Ph.D., Professor of Biochemistry and Molecular Biology at LSU Health New Orleans School of Medicine, has shown for the first time that a tiny piece of RNA deregulates energy metabolism, an ...

Cancer patients may experience delayed skin effects of anti-PD-1 therapy

July 18, 2018
Cancer patients receiving anti-PD-1 therapies who develop lesions, eczema, psoriasis, or other forms of auto-immune diseases affecting the skin may experience those adverse reactions on a delay—sometimes even after treatment ...

Early supper associated with lower risk of breast and prostate cancer

July 18, 2018
Having an early supper or leaving an interval of at least two hours before going to bed are both associated with a lower risk of breast and prostate cancer. Specifically, people who take their evening meal before 9 p.m. or ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.