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AstraZeneca's sNDA for Two Cancer Drugs Gets Priority Review

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AstraZeneca, plcAZN and partner Merck MRK announced that the FDA has granted priority review to its supplemental New Drug Application (sNDA) for Lynparza. With this sNDA, AstraZeneca and Merck are looking to expand the label of Lynparza, presently marketed for advanced ovarian cancer, to an advanced breast cancer indication.

The sNDA, looking to get the drug approved for previously treated (chemotherapy) patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations, was based on data from the phase III OlympiAD study. With the FDA granting priority review, the FDA is expected to give its decision in the first quarter of 2018.

The sNDA is also the first regulatory application of this PARP inhibitor beyond ovarian cancer

Lynparza is in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.

Competition in the PARP inhibitor market has become fierce with Clovis Oncology, Inc.'s CLVS Rubraca, launched in December 2016, doing well and Tesaro, Inc. TSRO launching Zejula (niraparib), in April.

In a separate press release, AstraZeneca announced that the FDA has also granted priority review to its sNDA for key cancer drug, Imfinzi for an earlier stage of lung cancer disease. The sNDA was based on data from the phase III PACIFIC study. Interim data from the study, presented in September, showed that Imfinzi led to superior progression-free survival compared to standard of care in patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have not progressed following chemoradiation.

Imfinzi was launched in the United States for the first indication - second line advanced bladder cancer - in May. Imfinzi is being evaluated for multiple cancers (either alone or in combination with other regimens), including phase III trials in combination with tremelimumab in first-line urothelial cancer, NSCLC, small cell lung cancer and head and neck squamous cell carcinoma (HNSCC) among others.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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