AstraZeneca receives raft of EU drug approvals and recommendations to end 2022
AstraZeneca has ended the year with a raft of EU drug approvals and recommendations.
Lynparza, in combination with abiraterone, was approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer.
Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said: “Many patients with metastatic castration-resistant prostate cancer are only able to receive one line of active therapy, as the disease can progress quickly.
“Lynparza in combination with abiraterone has been shown to reduce the risk of disease progression by 34 per cent versus the standard of care treatment in the PROpel trial. Moreover, the combination of Lynparza with abiraterone as a first-line treatment expands the use of Lynparza to a broader group of metastatic castration-resistant prostate cancer patients than those treated with Lynparza alone in the second-line setting in the PROfound trial. Today’s approval marks a significant advance toward addressing the unmet need of patients with metastatic castration-resistant prostate cancer in the EU.”
Imfinzi, plus chemotherapy, was approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer.
Enhertu, meanwhile, was approved in the EU for patients with previously treated HER2-positive advanced gastric cancer. It was also recommended for approval in the EU by the Committee for Medicinal Products (CHMP) for Human Use for patients with HER2-low metastatic breast cancer.
CHMP also recommended EU approval of Imfinzi plus Imjudo for the treatment of advanced liver and lung cancers. And it recommended Forxiga for approval in the EU for symptomatic chronic heart failure.