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AstraZeneca PLC on Monday said in won three recommendations for approval for the treatment of adults with cancers in the European Union from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The Cambridge-based pharmaceutical company said Lynparza, in combination with cancer drug abiraterone, received recommendation as first-line treatment of metastatic castration-resistant prostate cancer.
The CHMP decided its recommendation based on a phase 3 trial published in June 2022. It showed Lynparza plus abiraterone reduced the risk of disease progression or death by 34% compared to abiraterone alone.
"Median radiographic progression-free survival was 24.8 months for Lynparza plus abiraterone versus 16.6 months for abiraterone alone," AstraZeneca explained.
AstraZeneca's Imfinzi gained recommendation for approval in unresectable or metastatic biliary tract cancer when in combination with chemotherapy.
This recommendation was based on a phase 3 study showing a 24% risk of death reduction compared to chemotherapy alone. The median overall survival rate was 12.9 months for Imfinzi with chemotherapy versus 11.3 months for only chemotherapy.
Meanwhile, Enhertu, which AstraZeneca develops with its Tokyo-based partner Daiichi Sankyo Co Ltd, won recommended approval in the treatment of advanced human epidermal growth factor receptor 2 positive gastric cancer in those who have received a prior regimen of trastuzumab, another cancer drug.
This was based on a phase 2 study showing an objective response rate of 51% compared to 14% with chemotherapy.
AstraZeneca shares were 1.8% higher at 10,792.00 pence each in London on Monday morning. Meanwhile, Daiichi Sankyo closed down 5.3% at JP¥4,410.00 in Tokyo.
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