AstraZeneca's Datroway: A New Hope for Breast Cancer Patients
Monday, Jan 20, 2025 3:28 pm ET
2min read AstraZeneca, in collaboration with Daiichi Sankyo, has secured approval from the U.S. Food and Drug Administration (FDA) for its novel antibody drug conjugate (ADC), Datroway (datopotamab deruxtecan-dlnk). This approval is a significant milestone in the treatment of breast cancer, offering a new alternative to conventional chemotherapy for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy.
Datroway is a specifically engineered TROP2-directed ADC, discovered by Daiichi Sankyo and jointly developed by AstraZeneca and Daiichi Sankyo. The approval was based on the results of the TROPION-Breast01 phase 3 trial, which demonstrated that Datroway significantly reduced the risk of disease progression or death by 37% compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR-positive, HER2-negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with Datroway versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the Datroway arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the Datroway arm compared to 5.7 (95% CI: 4.9-6.8) in the chemotherapy arm.
The approval of Datroway is a testament to AstraZeneca's commitment to developing innovative cancer treatments and expanding its ADC portfolio. Datroway is the second ADC approved in the U.S. based on Daiichi Sankyo's DXd ADC Technology, following the approval of Enhertu in 2019. This approval also marks the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030, further solidifying the company's position in the oncology market.
Datroway's approval is expected to have a positive impact on AstraZeneca's oncology portfolio and revenue growth strategy. By addressing an unmet need in breast cancer and offering a new alternative to conventional chemotherapy, Datroway can capture a share of the market and generate additional revenue. Additionally, the approval of Datroway allows AstraZeneca to diversify its revenue streams by targeting a different patient population (HR-positive, HER2-negative) compared to Enhertu (HER2-positive).
However, Datroway's safety profile may limit its market share potential. The drug has been associated with a 4.2% rate of interstitial lung disease (ILD) or pneumonitis, with 0.5% of patients experiencing Grade 3-4 ILD/pneumonitis and 0.3% with fatal ILD/pneumonitis. Additionally, six patients (1.7%) permanently discontinued Datroway due to ILD/pneumonitis. These safety concerns may place Datroway lower on a physician's list of available therapies, as patients with advanced breast cancer have other treatment options.
In conclusion, AstraZeneca's approval of Datroway is a significant milestone in the treatment of breast cancer, offering a new alternative to conventional chemotherapy for patients with HR-positive, HER2-negative metastatic breast cancer. While Datroway's safety profile may limit its market share potential, its approval is expected to have a positive impact on AstraZeneca's oncology portfolio and revenue growth strategy. As AstraZeneca continues to deliver on its ambition for ADCs to improve upon and replace conventional chemotherapy, Datroway represents a crucial addition to the company's portfolio of innovative cancer treatments.
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