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AstraZeneca's PARP Inhibitor Lynparza Gets Approval in Japan
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AstraZeneca (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.
Lynparza becomes the first PARP inhibitor approved for any indication in Japan.
We remind investors that Lynparza’s prospects got a boost with its line expansion in breast cancer earlier this month in the United States. The expansion of label and geography will certainly boost sales of the drug. Meanwhile, the label expansion application to include breast cancer is under review in Europe.
AstraZeneca’s shares have increased 30.7% in the last year, while shares of Merck are down 0.9% in that period. Meanwhile, the industry moved up 23.9% in the same time period.
The approval was granted based on encouraging data from phase II study – Study 19 – and phase III study – SOLO-2. Both the studies evaluated Lynparza monotherapy in maintenance setting against placebo.
Data from SOLO-2 study showed that Lynparza improved median progression free survival (“PFS”) to 19.1 months compared to 5.5 months for placebo. Similarly, data from Study 19 trial demonstrated that the drug achieved a PFS of 8.4 months versus 4.8 months for placebo. The drug also achieved a median overall survival (“OS”) of 29.8 months against 27.8 months for placebo. Median OS is yet to be reached in SOLO-2 study.
Clovis Oncology, Inc.’s Rubraca and Tesaro, Inc.’s Zejula are the other PARP inhibitors, which give competition to Lynparza in the United States.
In a separate press release, AstraZeneca announced that Fasenra (benralizumab) was also granted approval as an add-on treatment for bronchial asthma in Japan. The drug was approved in patients who continue to experience asthma exacerbations despite receiving treatment with high-dose inhaled corticosteroid and other asthma controllers.
The approval was based on data from the WINDWARD program, which included three phase III studies – SIROCCO, CALIMA and ZONDA.
Data from SIROCCO and CALIMA showed that Fasenra achieved significant reductions in exacerbations and improvements in lung function. Meanwhile, data from ZONDA study showed that Fasenra alone or in combination with standard of care (glucocorticoid) led to statistically-significant and clinically relevant reduction in daily maintenance oral corticosteroid (“OCS”) compared with placebo.
Other severe asthma candidates in AstraZeneca’s portfolio are tralokinumab and tezepelumab — in partnership with Amgen.
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
AstraZeneca's PARP Inhibitor Lynparza Gets Approval in Japan
AstraZeneca (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.
Lynparza becomes the first PARP inhibitor approved for any indication in Japan.
We remind investors that Lynparza’s prospects got a boost with its line expansion in breast cancer earlier this month in the United States. The expansion of label and geography will certainly boost sales of the drug. Meanwhile, the label expansion application to include breast cancer is under review in Europe.
AstraZeneca’s shares have increased 30.7% in the last year, while shares of Merck are down 0.9% in that period. Meanwhile, the industry moved up 23.9% in the same time period.
The approval was granted based on encouraging data from phase II study – Study 19 – and phase III study – SOLO-2. Both the studies evaluated Lynparza monotherapy in maintenance setting against placebo.
Data from SOLO-2 study showed that Lynparza improved median progression free survival (“PFS”) to 19.1 months compared to 5.5 months for placebo. Similarly, data from Study 19 trial demonstrated that the drug achieved a PFS of 8.4 months versus 4.8 months for placebo. The drug also achieved a median overall survival (“OS”) of 29.8 months against 27.8 months for placebo. Median OS is yet to be reached in SOLO-2 study.
Clovis Oncology, Inc.’s Rubraca and Tesaro, Inc.’s Zejula are the other PARP inhibitors, which give competition to Lynparza in the United States.
In a separate press release, AstraZeneca announced that Fasenra (benralizumab) was also granted approval as an add-on treatment for bronchial asthma in Japan. The drug was approved in patients who continue to experience asthma exacerbations despite receiving treatment with high-dose inhaled corticosteroid and other asthma controllers.
The approval was based on data from the WINDWARD program, which included three phase III studies – SIROCCO, CALIMA and ZONDA.
Data from SIROCCO and CALIMA showed that Fasenra achieved significant reductions in exacerbations and improvements in lung function. Meanwhile, data from ZONDA study showed that Fasenra alone or in combination with standard of care (glucocorticoid) led to statistically-significant and clinically relevant reduction in daily maintenance oral corticosteroid (“OCS”) compared with placebo.
Other severe asthma candidates in AstraZeneca’s portfolio are tralokinumab and tezepelumab — in partnership with Amgen.
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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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