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AstraZeneca's (AZN) Lynparza NDA Accepted for Review by FDA

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AstraZeneca plc (AZN - Free Report) announced that the FDA has accepted the new drug application (NDA) for Lynparza (300mg twice daily) for the maintenance treatment of patients suffering from platinum sensitive relapsed ovarian cancer with the germline BRCA mutation. The drug has also been granted a priority review status with a PDUFA date set for the third quarter of 2017.

The acceptance of the NDA was based on positive results from a phase III study, SOLO-2. The priority review status from the FDA will speed up the review of the NDA within 6 months of submission compared with the standard 10-month review timeline. AstraZeneca’s shares have outperformed the Zacks classified Large Cap Pharma industry so far this year. Its shares have increased 14.7%, while the industry gained 6.8%.

The SOLO-2 study evaluating germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients, met its primary end point. Data from the study showed that Lynparza tablets reduced risk of disease progression by 70% and met investigator-assessed progression-free survival (PFS) of 19.1 months vs 5.5 months compared to placebo.

Results were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. Going forward, if the tablet formulation receives approval, the 300mg twice-daily tablet dose will reduce the pill burden for patient.

We note that Lynparza capsules (400mg twice daily) are currently approved in the U.S. as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

The drug has registered sales of $218 million in 2016 compared with $94 million in 2015.

However, Lynparza tablets are still in investigational formulation and are not FDA-approved for any indication.

Meanwhile, AstraZeneca is also evaluating the potential of Lynparza in other PARP dependent tumors. Currently, phase III studies on Lynparza are ongoing for several indications like breast cancer, pancreatic cancer and prostate cancer among others along with additional studies being planned.

Clovis Oncology, Inc.’s advanced ovarian cancer treatment, Rubraca tablets, was approved by the FDA in December last year. Clovis in-licensed Rubraca from Pfizer, Inc. (PFE - Free Report) in 2011.

Zacks Rank & Key Picks

AstraZeneca is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the Large Cap Pharma sector is Roche Holding AG (RHHBY - Free Report) , which holds a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Roche’s earnings estimates increased from $1.70 to $1.90 for 2017 over the last 30 days.

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