AstraZeneca.JPG” style=”padding: 10px” width=”285″ />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.
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"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.
