AstraZeneca (AZN.L) said on Thursday that a combination of its cancer drug Lynparza and abiraterone has been approved in the United States for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have previously received chemotherapy.
The drug combination, known as 'Lynparza plus abiraterone acetate', is the first and only treatment to be approved for mCRPC patients who have previously received chemotherapy. The combination was approved by the U.S. Food and Drug Administration (FDA) under the accelerated approval program.
Accelerated approval is granted to drugs that show promise in treating a serious illness, even if they have not yet been shown to be better than existing treatments. AstraZeneca will need to conduct a confirmatory study to prove that the drug combination is effective in extending the lives of mCRPC patients.
In the clinical trial that led to the approval of the drug combination, patients who received the combination had a median overall survival of 16.3 months, compared with 13.6 months for patients who received abiraterone acetate alone. The combination also led to a significant improvement in quality of life.
"This approval is a significant milestone for patients with mCRPC, who have limited treatment options," said Susan Galbraith, executive vice president of global medicines development and chief medical officer at AstraZeneca. "Lynparza plus abiraterone acetate is the first and only treatment to be approved for this patient population, and we are committed to providing it to patients as quickly as possible."
The approval of the drug combination is a major win for AstraZeneca, which has been struggling to maintain its market share in the cancer drug market. The company's flagship cancer drug, Avastin, is facing increasing competition from generics and other newer drugs.
The approval of Lynparza plus abiraterone acetate is a sign that AstraZeneca is still capable of developing innovative cancer drugs. The drug combination is expected to generate significant revenue for AstraZeneca, and it could help the company to regain some of its lost market share.
Analysis
The approval of AstraZeneca's Lynparza plus abiraterone acetate combination for the treatment of mCRPC is a significant development in the treatment of this cancer. The combination is the first and only treatment to be approved for this patient population, and it has the potential to offer a significant improvement in survival and quality of life.
The approval of the combination is based on the results of a clinical trial that showed that patients who received the combination had a median overall survival of 16.3 months, compared with 13.6 months for patients who received abiraterone acetate alone. The combination also led to a significant improvement in quality of life.
The approval of the combination is a major win for AstraZeneca, which has been struggling to maintain its market share in the cancer drug market. The company's flagship cancer drug, Avastin, is facing increasing competition from generics and other newer drugs.
The approval of Lynparza plus abiraterone acetate is a sign that AstraZeneca is still capable of developing innovative cancer drugs. The drug combination is expected to generate significant revenue for AstraZeneca, and it could help the company to regain some of its lost market share.
The approval of the combination is also a positive development for patients with mCRPC. The combination offers a new treatment option for this patient population, and it has the potential to offer a significant improvement in survival and quality of life.
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