AstraZeneca shares two new drug approvals in the EU
pharmafile | December 22, 2022 | News story | Medical Communications |
On Wednesday, AstraZeneca announced two drug approvals in the European Union (EU). The first being Imfinzi’s approval for the treatment of biliary tract cancer, and the latter being Lynparza for prostate cancer.
The European Commission (EC) approved Imfinzi, also known as durvalumab, for the first-line treatment of adult patients with unresectable or metastatic biliary tract cancer, in combination with chemotherapy. This approval was based on results from the TOPAZ-1 phase 3 trial, as well as considering the updated results presented at the European Society for Medical Oncology Congress 2022. The drug was also recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in November.
Dave Fredrickson, executive vice-president of the oncology business unit, commented: “With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer.”
Similarly, Lynparza, also known by olaparib, in combination with abiraterone and prednisone or prednisolone, was approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who chemotherapy was not recommended for.
This approval was based on results from the PROpel phase 3 trial, and followed another positive recommendation from the Committee for Medicinal Products for Human Use in November.
Fredrickson commented: “Many patients with mCRPC 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% versus the standard of care treatment in the PROpel trial.”