US approves broad label expansion for AstraZeneca's Lynparza  

AstraZeneca and partner Merck & Co. announced that the FDA expanded approval for the PARP inhibitor Lynparza (olaparib) in ovarian cancer. Specifically, the agency cleared the switch to a new formulation of Lynparza consisting of two tablets twice-daily, from the current eight-capsule regimen given twice a day, as maintenance therapy for women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

In addition, Lynparza tablets also obtained full approval to treat BRCA-mutated advanced ovarian cancer beyond the third-line setting based on an FDA-approved companion diagnostic. The agency initially granted the drug accelerated approval for this indication in 2014 based on a single-arm trial.

The companies said the expanded label and conversion to full approval were supported by data from two randomised studies. In the Phase III SOLO-2 trial, Lynparza was associated with a significant 70-percent reduced risk of disease progression or death in relapsed ovarian cancer patients with germline BRCA mutations, improving median progression-free survival (PFS) to 19.1 months, versus 5.5 months for placebo. 

Meanwhile, data from mid-stage Study 19 demonstrated that Lynparza cut the risk of disease progression or death by 65 percent in patients with relapsed ovarian cancer regardless of BRCA status, prolonging median PFS to 8.4 months, versus 4.8 months for placebo.

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Commenting on the news, Baird Equity analyst Michael Ulz said the expanded approval makes Lynparza more competitive with Tesaro's PARP inhibitor Zejula (niraparib), which the FDA cleared in March for the maintenance treatment of recurrent ovarian cancer in patients irrespective of BRCA status. For related analysis, see ViewPoints: New Lynparza label codifies PARPs as commodity to Tesaro's chagrin

Last month, AstraZeneca and Merck entered into a partnership potentially worth up to $8.5 billion to jointly develop and market Lynparza for multiple cancer indications, including breast, prostate and pancreatic cancers. Under the deal, AstraZeneca and Merck plan to develop the PARP inhibitor both as monotherapy and in combination trials with other potential medicines, including their respective PD-L1 and PD-1 drugs, Imfinzi (durvalumab) and Keytruda (pembrolizumab). Roger Perlmutter, president of Merck Research Laboratories, remarked "this is a significant first regulatory event in our collaboration with AstraZeneca."

Lynparza was also approved in Europe in 2014 for use in women with advanced BRCA-mutated ovarian cancer. 

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