AstraZeneca, plc (AZN - Free Report) and partner Merck (MRK - Free Report) 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 Rubraca, launched in December 2016, doing well and Tesaro, Inc. 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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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
AstraZeneca, plc (AZN - Free Report) and partner Merck (MRK - Free Report) 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 Rubraca, launched in December 2016, doing well and Tesaro, Inc. 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.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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