AstraZeneca Says FDA Oks Lynparza For Metastatic Breast Cancer

Breast cancer survival 'unaffected' by presence of faulty gene

Scientists at the University of Southampton, UK, recently reported that women who carry a mutation in the BRCA1 or BRCA2 genes are not more likely to die after a breast cancer diagnosis than non-carriers.

The most recent indication approved for the drug is the third, making it the only PARP inhibitor regulated in metastatic breast cancer, and the only PARP inhibitor approved in more than one tumor type.

Survival rates after two years were 97 percent for women with a BRCA mutation and 96.6 percent for those without the mutation, the findings showed. 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.

Mutations in these genes stop DNA repairing itself and increase the risk of cancer developing. "The fact that in the POSH study there were 155 young women diagnosed with breast cancer who did not know their mutation status raises the question of whether and when testing criteria for certain groups of patients can be allowed for lower mutation probabilities".

For the study, called POSH (Prospective Outcomes in Sporadic versus Hereditary), the researchers recruited female patients from 127 hospitals in the United Kingdom who were ages 18 to 40 when first diagnosed with invasive breast cancer, excluding those with a previous invasive malignancy.


The BRCA1 or BRCA2 gene mutations were dubbed the 'Angelina Jolie gene' after the actress underwent preventative surgery when she discovered she had an up to 87 percent chance of developing breast cancer.

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. This was true at 2, 5 and 10 years following diagnosis.

Patients with hormone receptor positive (HR+) breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Olaparib significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression by 42%. Women taking Lynparza should not breastfeed as it could cause harm to a newborn baby.

Fiona MacNeill, of the Royal Marsden NHS Foundation Trust, who was not involved in the research, said: "This study can reassure young women with breast cancer, particularly those with triple negative cancer or who are BRCA carriers, that breast conservation with radiotherapy is a safe option in the first decade after diagnosis and double mastectomy is not essential or mandatory at initial treatment".

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Related news:

Hot News

isis-killer-beheading-video-story-top Queen Elizabeth gets candid about 'disadvantages to crowns'
Jan 14, 2018 - 12:43
Thompson even had a couple of corgis accompanying her in her royal week out, the signature companions of the real queen . Though it was known the jewels had been taken to the castle for safekeeping, details had not been widely discussed.

isis-killer-beheading-video-story-top Amid Ahed Tamimi Imprisonment, Two 16-Year-Old Palestinians Killed by Israel
Jan 14, 2018 - 12:42
According to a statement, four people, including a first aid officer of the Red Crescent, were injured by the Israeli police. Two other Palestinians were injured and transferred to the Shuhada al-Aqsa Hospital in Deir al-Balah along with Abu Musaed.

isis-killer-beheading-video-story-top We Can Use NAFTA to Pay for Border Wall
Jan 14, 2018 - 12:39
He didn't elaborate on what that means. "They can pay for it indirectly through Nafta", the newspaper quoted Trump as saying. Canadian officials said this week there's an increased likelihood Trump will follow through on his exit threat.

isis-killer-beheading-video-story-top #TimesUp: 'Bonds, like men, are in a bear market,' says Bill Gross
Jan 14, 2018 - 12:38
The holdings increased by 6.6% from a year earlier, but were down from a 12-month peak of $1.2 trillion in August. Buying Treasuries keeps the dollar stronger relative to the yuan, which has helped Chinese exports in the past.

isis-killer-beheading-video-story-top The future 5 at the Australian Open
Jan 14, 2018 - 12:37
But he admitted he can not give himself a clear bill of health until he plays in the Australian Open next week. Andy Murray and Novak Djokovic arrived here one year ago as the top two seeds at the Australian Open .

isis-killer-beheading-video-story-top LG Reveals First 8K Resolution 88-Inch OLED TV Of The World
Jan 14, 2018 - 12:33
Since it's an 8K OLED display, we can expect high quality TV, deep black levels, and extremely bright colors. The 8K resolution provides intense pixel density, making the visual crystal-clear and stunning.

isis-killer-beheading-video-story-top Slain Pakistani girl may have been victim of serial killer
Jan 14, 2018 - 12:29
It is the 12th such murder in the town of Kasur in a year, and has raised concerns that a serial killer may be on the loose. Zainab's parents returned from their pilgrimage on Wednesday but they were unable to attend their child's funeral prayers.

isis-killer-beheading-video-story-top Blue Jays sign star Josh Donaldson to one-year, $23-million deal
Jan 13, 2018 - 05:44
The Toronto Blue Jays and third baseman Josh Donaldson avoided arbitration on Friday, at a reported record $23million. He went 1-3 with a 4.25 ERA, after an All-Star season in 2016 in which he was 15-2 with an AL-best 3.00 ERA.

Mueller Appoints Cyber Expert to Trump Probe Team
Jan 13, 2018 - 05:43
The special counsel's team of investigators has expressed interest in speaking with Trump , but no details have been worked out. Serious questions have been raised as to whether Mueller's team of Trump-hating partisans is conducting a fair investigation.

isis-killer-beheading-video-story-top Grassley: Hope Trump doesn't call me about Russian Federation probe
Jan 13, 2018 - 05:39
It "would be valuable to have [Ivanka] come and testify before the committee", he added, according to Politico . CNN published stories about some of Trump Jr.'s comments while his interview was still being conducted.

isis-killer-beheading-video-story-top Trump is open to talks with North Korea
Jan 13, 2018 - 05:38
North Korea has yet to comment on the South's offer, which is in the spirit of the original deal and even goes beyond it. Meanwhile, South Korea has already made headway to ensure it hosts the Winter Olympics without any diplomatic hiccups.

isis-killer-beheading-video-story-top Donald Trump Rages Against Iran, Pakistan In First Tweets Of 2018
Jan 13, 2018 - 05:38
The US has long accused Pakistan of providing safe heavens to the terrorists that the United State hunts in Afghanistan. Pakistan also enjoys certain privileges as one of 16 US 'Non-NATO Major Allies'.

isis-killer-beheading-video-story-top Powerful winter storm slams Island Park with blizzard-like conditions
Jan 13, 2018 - 05:38
Earlier in the week, winter weather brought unusually cold temperatures and snowfall to southern states, as far as Florida. Gusts of 75 miles per hour were recorded in Wellfleet, Mass., and a gust of 76 miles per hour was recorded in Nantucket.

isis-killer-beheading-video-story-top Chinese trade with North Korea plunged by 50% last month
Jan 13, 2018 - 05:37
President Donald Trump said that he "probaby [has] a very good relationship with Kim Jong Un", the North Korean leader. But there was a desire on the Canadian side to invite the Chinese to Vancouver for side meetings.

isis-killer-beheading-video-story-top Seeking a bipartisan deal on immigration
Jan 13, 2018 - 05:36
Bob Goodlatte , R-Va., left, listened as House Homeland Security Border and Maritime Security Subcommittee Chairwoman Rep. But if he rejects a bipartisan deal to shore up his hard line base, it's Trump - not Congress - shutting government down.