AstraZeneca is celebrating a green light in Europe for its PARP inhibitor Lynparza as a treatment for ovarian cancer.
The EMA approval means Lynparza (olaparib) has become the first therapy for the maintenance treatment of platinum-sensitive relapsed BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer patients who are in complete or partial response to platinum-based chemotherapy.
The milestone represents a remarkable turnaround for Lynparza, which was shelved by AZ at the end of 2011 after disappointing results in a phase II trial. A re-analysis of the data from that study, as well as a re-formulation to improve its dosing regimen - led the company to start pivotal trials in September 2013.
PARP (poly ADP-ribose polymerase) inhibitors work by blocking the repair of DNA in tumour cells, and Lynparza is the first drug in the class to be approved for marketing, beating rivals such as Merck & Co/Tesaro's niraparib and AbbVie's veliparib which are in phase III testing in ovarian and breast cancer, respectively.
Lynparza's approval in the US was held up in the US earlier this year, however, after the FDA turned down a request for accelerated approval and asked for data, while Sanofi was forced to abandon development of its iniparib candidate, which had been in trials for breast and non-small cell lung cancer (NSCLC).
"We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited," said Briggs Morrison, AZ's chief medical officer.
"Today's news marks only the first of what we hope will be a number of indications in which Lynparza has the potential to transform the lives of cancer patients, including those with breast, pancreatic and gastric cancers," he added.
Medical charity Target Ovarian Cancer described olaparib as "an important new drug" when the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on AZ's application earlier this month.
TOC's head of research Simon Newman said that the results of AZ's II trial "look promising" and would be the basis of an ongoing NICE consultation that will determine the drugs availability in the UK.
"We eagerly await the outcomes of the larger ongoing Phase III trial in to see if the progression-free survival benefit seen in women with a BRCA-related cancer is upheld," he added, noting that studies have also suggested PARP inhibitors could potentially benefit ovarian cancer patients without the BRCA mutation.