EU approval recommended for three drugs from AstraZeneca
AstraZeneca has announced that three of its drugs have been recommended for EU approval. The three drugs are: Imfinzi, Enhertu and Lynparza, all of which can be used to treat different cancers.
Imfinzi can be used in combination with chemotherapy as an immunotherapy treatment for advanced biliary tract cancer; Enhertu can be used for patients with previously treated HER2-positive advanced gastric cancer; and Lynparza can be used in combination with abiraterone to treat metastatic castration-resistant prostate cancer.
In the PROpel phase 3 trial, Lynparza, in combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% in comparison with abiraterone alone. Progression-free survival was 24.8 months for Lynparza with abiraterone, compared to 16.6 months for just abiraterone.
Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, said, “If approved, Lynparza in combination with abiraterone and prednisone or prednisolone will represent the first combination of a PARP inhibitor and new hormonal agent available to patients in the EU.”
Results from the TOPAZ-1 phase 3 trial showed that Imfinzi alongside chemotherapy reduced the risk of death by 20% compared to chemotherapy alone. The median overall survival is reported as 12.9 months with Imfinzi, compared to 11.3 with chemotherapy alone.
Susan Galbraith commented: “If approved, Imfinzi plus chemotherapy will provide patients with advanced biliary tract cancer the first opportunity for treatment with an immunotherapy-based combination.”
Finally, results from the DESTINY-Gastric02 and DESTINY-Gastric01 phase 2 trials, showed Enhertu had a confirmed objective response rate of 41.8%. The average duration of response was 8.1 months, while average overall survival was 12.2 months. The drug saw a 40% reduction in the risk of death compared to patients treated with chemotherapy alone.
Susan Galbraith added: “Gastric cancer is usually diagnosed in the advanced stage in many European countries and patients face high mortality rates. If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade.”