FDA Approves Datroway by AstraZeneca, Daiichi Sankyo for Lung Cancer

The U.S. Food and Drug Administration (FDA) approved Datroway (datopotamab deruxtecan-dlnk), an innovative TROP2-directed antibody-drug conjugate by AstraZeneca and Daiichi Sankyo, with accelerated approval. The indication is that this is applicable to adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) that progressed after EGFR-targeted therapy and platinum-based chemotherapiserum.

The authorization is based on the TROPION-Lung05 and TROPION-Lung01, which showed an objective response rate of 45 % (ORR) in 114 patients and lasted a median of 6.5 months. Applied intravenously, Datroway, at 6 mg/kg given on a three-weekly basis, represents a unique therapy of patients having a few options following conventional care. The size of this approval is evident in the fact that 80 percent of lung cancer patients have NSCLC, whereas in the U.S. 10-15 percent of lung cancer patients have EGFR mutation.

Dave Fredrickson, Executive Vice President of AstraZeneca Oncology Haematology Business Unit stressed, “Today, we have important news to deliver, as this approval offers a new treatment option to patients with advanced lung cancer associated with EGFR mutation with resistance to previous therapies.” Andrea E. Ferris, the CEO of LUNGevity, shared this opinion adding that such patients have a few options.

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The safety profile of Datroway matches previous findings; however, risk warnings comprise risks of interstitial lung disease, eye harm, and stomatitis. It is a second-time around FDA approval on Datroway products which was already approved on the HR- positive, HER 2 negative breast cancer. The use of it in concurrence with Tagrisso is currently being evaluated in the active trials, such as TROPION-Lung14 and TROPION-Lung15.

Such authorisation is significant in that it makes Datroway the first CORP2-targeted therapy against lung cancer in America; a hope that raise among patients suffering the violent disease.