AstraZeneca announces two drug approvals in the EU

AstraZeneca announced two EU approvals on Wednesday, with Imfinzi approved for biliary tract cancer, and Lynparza for prostate cancer.

The FTSE 100 pharmaceuticals giant said Imfinzi, or durvalumab, was approved for the first-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC), in combination with chemotherapy.

It said the approval by the European Commission was based on the primary results from the TOPAZ-1 phase 3 trial, and on the updated results presented at the European Society for Medical Oncology Congress 2022.

The approval followed the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in November.

“With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer,” said Dave Fredrickson, executive vice-president of the oncology business unit.

“This approval underscores our commitment to transform survival outcomes while addressing the high unmet need for new and improved treatments for patients with hepatobiliary cancers.”

Lynparza, or olaparib, in combination with abiraterone and prednisone or prednisolone, was meanwhile approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy was not clinically indicated.

The company said the EC approval was based on results from the PROpel phase 3 trial, and also followed a positive recommendation by the Committee for Medicinal Products for Human Use in November.

“Many patients with metastatic castration-resistant prostate cancer are only able to receive one line of active therapy, as the disease can progress quickly,” Dave Fredrickson explained.

“Lynparza in combination with abiraterone has been shown to reduce the risk of disease progression by 34% 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.”

At 0933 GMT, shares in AstraZeneca were up 0.16% at 11,140p.

Reporting by Josh White for Sharecast.com.