The European Union has approved Daiichi Sankyo and AstraZeneca’s monoclonal antibody  conjugate, trastuzumab deruxtecan, marketed as Enhertu as monotherapy for the treatment of advanced HER2 positive gastric or gastroesophageal junction (GEJ) cancers who have received a prior trastuzumab-based treatment.

In a statement released recently, the Tokyo-based biopharmaceutical major said that with the approval, Enhertu became the first HER2-directed medicine to be approved for gastric cancer in the EU in more than a decade.

Daiichi said that the antibody-drug conjugate received approval based on the trial data involving patients from Europe and North America, resulting in a confirmed objective response rate (ORR) of 41.8%, an important parameter in determining the efficacy of any treatment, as assessed by independent central review.

“Today’s news is a welcome advance for patients with HER2 positive advanced gastric cancer,” Dr Eric Van Cutsem, Head of the Department of Oncology, University of Leuven, Belgium and Founding Chair of the ESMO-GI/World Congress of Gastrointestinal Cancers said.

“Patients with this disease face poor outcomes following progression on initial treatment with a HER2-directed medicine as many do not respond to further treatment, and even those that do respond often do not have durable responses,” he added.

Available data suggest that each year approximately 136,000 cases of gastric cancers are diagnosed across Europe, most of them at advanced stages, thereby influencing the outcome of the disease.

Pointing out that Enhertu is the first antibody-drug conjugate to be approved in Europe for advanced gastric cancer, representing a major advance in treating this difficult-to-treat cancer,” Ken Keller, Global Head of Oncology Business and President and CEO, Daiichi Sankyo said, “With this approval, we can now offer patients with previously treated HER2 positive gastric cancer a treatment with clinically meaningful efficacy.”

“Today’s important approval makes Enhertu the first HER2-directed medicine to be approved for gastric cancer in the European Union in more than a decade,” Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca, said.

“Patients across the EU with advanced HER2-positive disease who have progressed following treatment in the first-line setting may now have the potential opportunity to benefit from treatment with Enhertu,” he added.