AstraZeneca/Merck's Lynparza Wins EU Nod For First-Line Use

AstraZeneca plc. (NYSE:AZN) and partner Merck (NYSE:MRK) announced that the European Commission (EC) has granted marketing approval to their PARP inhibitor Lynparza for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer. It was approved in the United States for the indication in late 2018.

With the latest approval, Lynparza can now be used as maintenance monotherapy for the treatment of advanced ovarian cancer patients with BRCA1/2 mutation who have achieved complete or partial response, following first-line standard platinum-based chemotherapy. The regulatory filing was based on data from the phase III SOLO-1 study, which showed that 60% of patients treated with Lynparza remained free of disease progression
after three years versus 27% on placebo.

The approval was expected as in April the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion recommending this label expansion of Lynparza. In April, Lynparza was also approved by EC for the breast cancer indication for which it was approved in the United States in early 2018.

Lynparza is presently approved for multiple indications in advanced ovarian cancer and metastatic breast cancer. It is also being evaluated in different studies for a range of tumor types including prostate, pancreatic and gastric cancers as well as earlier-line settings for ovarian cancer and breast cancer. A key phase III study, PAOLA-1 is evaluating Lynparza in combination with Roche’s Avastin as a first-line maintenance treatment for women with newly-diagnosed, advanced ovarian cancer, regardless of the BRCA status.

Other PARP inhibitors available in the market are Tesaro’s Zejula and Clovis Oncology, Inc.’s (NASDAQ:CLVS) Rubraca. Tesaro is now part of GlaxoSmithKline (NYSE:GSK) . However, Lynparza is the only PARP inhibitor approved in the EU as a first-line maintenance treatment for advanced ovarian cancer.

AstraZeneca’s stock has rallied 5.2% this year so far, outperforming the industry’s rise of 2.1%.

AstraZeneca reported Lynparza sales of $237 million in the first quarter of 2019, up 13.4% sequentially at constant exchange rates on the back of expanded use for ovarian and breast cancer. U.S. sales of the drug increased 80%, following a strong launch in first-line ovarian cancer setting in late 2018. The recent label expansion approvals in EU should boost sales further in the rest of the quarters of the year.

Lynpazra is a key drug in AstraZeneca’s oncology portfolio together with Tagrisso and Imfinzi. Oncology sales now comprise almost 35% of total product sales for AstraZeneca and rose 59% in the first quarter of 2019.

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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