The Institute of Cancer Research, London, strongly welcomes the news that olaparib has been approved by the US Food and Drug Administration (FDA) for patients with advanced breast cancer.
Professor Peter Fasching, from Friedrich-Alexander University Erlangen-Nuremberg, Germany, added: "This important topic needs more prospective research as preventive surgical measures might have an effect on what might be a very long life after a diagnosis of breast cancer at a young age".
For the new study, Eccles and a team recruited 2,733 British women aged 18-40 who had been diagnosed with breast cancer between 2000 and 2008. Half had breast-conserving surgery (49%), half had a mastectomy (50%), and less than 1% had no breast surgery.
It has been dubbed the "Angelina Jolie gene", after the actress revealed she underwent preventative surgery on learning she had an up to 87% chance of developing breast cancer. Lynparza helps block an enzyme involved in repairing damaged DNA.
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.
About 12 percent of the patients had a BRCA mutation, yet again confirming the association between this "faulty gene" and breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior hormonal (endocrine) therapy or be considered inappropriate for endocrine treatment.
In a subgroup of women with triple-negative breast cancer, those with a BRCA mutation had slightly higher survival rates for the first two years after diagnosis. Most importantly, they uncovered that there was no difference in overall survival two, five, or ten years after diagnosis for women with and without a BRCA mutation. Olaparib significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression by 42%.
The most common adverse reactions (20% or more) in the OlympiAD trial of patients who received olaparib were nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%) and headache (20%). Because Lynparza can harm a developing fetus, women are advised to use contraception while on the drug.
This application was granted Priority Review, under which the FDA's goal is to take action on an application within 6 months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
Lynparza is one of a group of powerful new cancer drugs known as PARP inhibitors, and it's the first such drug to be approved for use against breast cancer, the FDA noted.
Lynparza is produced by the British drug maker AstraZeneca, whose USA headquarters are in Wilmington, Del.