AstraZeneca steers another potential blockbuster drug
Based on TROPION-Lung05 results and supported by data from TROPION-Lung01, this is the first and only TROP2-directed therapy approved in the US to fight the disease.
AstraZeneca and commercial partner Daiichi Sankyo have high expectations for Datroway with the companies projecting peak annual sales of at least $5 billion. It has already received its first global approval in Japan and the US for treating certain types of breast cancer, and is also being evaluated for use in lung cancer.
It has now been approved in he States to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
This indication is backed under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation. We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community.”
Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, added: “With this accelerated approval, Datroway is now the first TROP2-directed medicine available for certain patients in the US living with lung cancer. We remain committed to our extensive clinical development programme to further identify where Datroway may be used in other types of lung and breast cancer.”
AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials. Following the US approval AstraZeneca is due to pay $45 million to Daiichi Sankyo as a milestone payment.
