AstraZeneca and Daiichi Sankyo's Datroway Secures Second FDA Approval for Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Datroway, a collaborative product from AstraZeneca and Daiichi Sankyo, for the treatment of locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). This marks the second FDA approval for Datroway, following its initial nod for metastatic HR-positive, HER2-negative breast cancer earlier this year.

Expanding Treatment Options for NSCLC Patients

Datroway, now the first TROP2-directed therapy approved in the U.S. for NSCLC, offers a new option for patients who have previously received EGFR-related treatment and platinum-based chemotherapy. Dr. Jacob Sands of the Dana-Farber Cancer Institute, an investigator in two pivotal trials, emphasized the significance of this approval, stating, "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."

The approval was based on pooled data from a phase 3 trial and a subgroup analysis of a phase 2 study. Among 114 patients, Datroway demonstrated an impressive objective response rate of 45%, with 4.4% achieving a complete response. The median duration of response was 6.5 months.

Strategic Importance and Future Prospects

While EGFR mutations are present in only 10% to 15% of NSCLC cases in the U.S., this approval represents a crucial entry point for AstraZeneca and Daiichi Sankyo into the lung cancer market. The companies are currently awaiting results from a trial investigating Datroway in combination with AstraZeneca's Imfinizi as a first-line treatment for a broader NSCLC patient population.

Ken Keller, Daiichi Sankyo's global oncology head, reaffirmed the company's commitment to further exploring Datroway's potential, stating, "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."

Financial Implications and Collaboration Details

The approval triggers a $45 million milestone payment from AstraZeneca to Daiichi Sankyo, part of their $6 billion collaboration agreement established in 2020. This partnership, which included a $1 billion upfront payment, underscores AstraZeneca's confidence in Datroway's potential as a TROP2-directed therapy.

Datroway joins Enhertu as the second antibody-drug conjugate resulting from the AstraZeneca-Daiichi Sankyo collaboration. Enhertu, now in its sixth year on the market, generated impressive sales of $3.75 billion last year, setting high expectations for Datroway's commercial performance.