British-Swedish drugmaker AstraZeneca has obtained approval from the European Commission (EC) for its twice-daily Lynparza (olaparib) capsules (400mg).
Lynparza capsules can be first therapy to treat adult patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
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The drug was approved for patients who are in complete response or partial response to platinum-based chemotherapy.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor, which exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.
AstraZeneca global medicines development executive vice-president Briggs Morrison said: "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.
"We are committed to bringing new treatments to the patients who need them most and 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."
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By GlobalDataMarketing authorisation is said to be applicable to all 28 EU member states, along with Norway, Iceland and Liechtenstein.
The approval was based on data from a Phase II trial (Study 191), which assessed its efficacy and safety, compared to a placebo in platinum-sensitive relapsed high-grade serous ovarian cancer patients.
According to the company, the study demonstrated olaparib maintenance therapy significantly prolonged progression free survival (PFS), compared with a placebo in patients with BRCA-mutated ovarian cancer median PFS 11.2 months against 4.3 months.
AstraZeneca plans to investigate the full potential of olaparib in multiple tumour types, with Phase III studies in second-line gastric cancer, BRCA-mutated pancreatic cancer, as well as adjuvant and metastatic BRCA-mutated breast cancers underway.
Image: AstraZeneca’s R&D site in Mölndal, Sweden. Photo: courtesy of Erik031.
