FDA Approves Metastatic Breast Cancer Drug, Datroway
Datroway reduced disease progression by 37% when compared with chemotherapy.
metastatic breast cancer © Oksana Smyshliaeva - stock.adobe.com
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or metastatic hormone receptor HR+, HER2- breast cancer in adult patients who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease, according to a news release.
This approval is based on the results of the TROPION-Breast01 phase 3 trial which included 732 patients and found Datroway reduced disease progression by 37% when compared with chemotherapy. Datroway is AstraZeneca’s eighth of 20 new cancer drugs set to be available by 2030, Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said in the release.
Datroway is a Trop-2-directed antibody and topoisomerase inhibitor conjugate designed for intravenous use. Patients will receive 6 mg once every three weeks until the disease progresses, or maximum toxicity is reached within the body.
The most common adverse reactions to Datroway were stomatitis (59%) and nausea (56%). Additionally, 51% of patients also reported ocular problems, including dry eye (27%) and corneal infection or inflammation (24%). Patients may be prescribed eye drops or steroid mouth washes during treatment and should avoid wearing contact lenses, unless advised otherwise by a physician, according to the prescribing information.
Datroway may also cause rare but severe side effects such as interstitial lung disease and pneumonitis, which involve lung inflammation and scarring. These conditions occurred in 4.2% of patients during the trial.
This drug is not recommended for use in pregnant or breastfeeding women.
Breast cancer is the most diagnosed cancer among women in the United States, with more than 300,000 cases anually. The disease is categorized into four main subtypes: HR+/HER2-, HR-/HER2-, HR+/HER2+ and HR-/HER2+. The most common type, HR+, HER2, accounts for about 70% of all cases. Tumors in this subtype have receptors for estrogen or progesterone and no or low amounts of human epidermal growth factor receptor 2 proteins, meaning the tumors are less aggressive. It has a five-year survival rate of 91.2%. When the cancer becomes metastatic, five-year survival rates plummet to about 30%, according to the National Cancer Institute.
“Only one in three patients with metastatic HR-positive, HER2-negative breast cancer live more than five years following diagnosis, highlighting the urgent need for additional effective therapies,” Caitlin Lewis, senior vice president of strategy & mission at Living Beyond Breast Cancer, in the news release. “The approval of DATROWAY is a significant advance, offering patients with metastatic HR-positive breast cancer a new and much-needed treatment option.”
