The FDA has blessed AstraZeneca and Daiichi Sankyo’s Datroway to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The accelerated nod—which could hinge upon verification of clinical benefit in a confirmatory trial—applies to patients who have received prior EFGR-related treatment and platinum-based chemotherapy.
The label expansion comes five months after Datroway secured its first FDA nod, for patients with previously treated metastatic, HR-positive, HER2-negative breast cancer. With the nod, Datroway becomes the first TROP2-directed therapy in the U.S. for NSCLC.
“Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available,” Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in two trials that paved the way for the latest approval, said in a June 23 press release.
While only 10% to 15% of those who are diagnosed with NSCLC in the U.S. have EGFR mutations, the approval represents a key entry into the cancer type as the companies await results from a trial investigating Datroway and AZ’s Imfinizi as a combination treatment for a much larger patient population, those with first-line NSCLC.
“We remain committed to our extensive clinical development program to further identify where Datroway may be used in other types of lung and breast cancer,” Daiichi Sankyo's global oncology head Ken Keller said in a release.
The new nod was backed by pooled data from a phase 3 trial and a subgroup analysis of a phase 2 study. Among 114 patients, Datroway excelled in its primary efficacy measure of objective response rate, shrinking tumors in 45% of the participants, with 4.4% achieving a complete response. The median duration of response was 6.5 months.
Datroway is the second antibody-drug conjugate from the partner companies, following blockbuster Enhertu, which has been on the market for six years and generated sales of $3.75 billion last year.
AZ was so convinced of the potential of TROP2-directed Datroway in 2020 that it paid Daiichi $1 billion upfront for the collaboration, with an additional $5 billion tied to potential regulatory and sales milestones. With the new approval, AZ owes Daiichi $45 million. The Japanese company markets Datroway in the U.S.
In November, the companies pulled an FDA filing for Datroway in second-line nonsquamous NSCLC after a phase 3 study showed mixed results.