AstraZeneca's Lynparza Label Now Includes Breast Cancer

AstraZeneca, plc AZN and partner Merck MRK announced that the FDA has approved the supplemental New Drug Application (sNDA) for Lynparza seeking approval for label expansion in metastatic breast cancer. Lynparza is presently marketed for advanced ovarian cancer.

With the latest FDA approval, Lynparza can now be used to treat previously treated (chemotherapy) patients with HER2-negative metastatic breast cancer, harboring germline BRCA mutations. Moreover, the drug is also approved in patients with HR+ breast cancer who were treated with an endocrine therapy or were ineligible for the same.

The approval makes Lynparza the first approved PARP-inhibitor for treating metastatic breast cancer. Also, first time a PARP inhibitor has been approved beyond ovarian cancer

AstraZeneca’s shares have increased 24.8% in the last year, while shares of Merck are down 5.9% in that period. Meanwhile, the industry moved up 19.1% in the same time period.

 

The FDA approved the label expansion based on data from the phase III OlympiAD study, which evaluated Lynparza against a chemotherapy. The drug achieved significant improvement in progression-free survival (“PFS”) compared to chemotherapy (7.0 vs 4.2 months). Lynparza also reduced the risk of disease progression or death by 42% and achieved an objective response rate (“ORR”) of 52%, double compared to chemotherapy’s 23%.

Patients will be selected based on Myriad Genetics, Inc.’s MYGN FDA-approved companion diagnostic test.

Although there is no cure for metastatic breast cancer, Lynparza will offer a new treatment option which lengthens the duration of disease progression. Per the press release, there are 155,000 patients in the United States with metastatic breast cancer who have an inherited BRCA mutation.

Lynparza registered sales of $197 million in the first nine months of 2017, growing 26% year over year. This label expansion will certainly boost the prospect of the drug and give it an advantage over other drugs in the PARP inhibitor segment, which includes Clovis Oncology, Inc.’s CLVS Rubraca and Tesaro’s Zejula. Rubraca and Zejula are approved only for ovarian cancer. Both the drugs are also being developed in breast cancer.

Zacks Rank

AstraZeneca 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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Astrazeneca PLC (AZN) : Free Stock Analysis Report
 
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