- First US approval for breast cancer drug
- Treatment reduces risk of death by 37%
- Eighth new medicine out of 20 set to deliver by 2030
AstraZeneca (AZN) said the US FDA (Food and Drug Administration) has approved its cancer treatment Datroway to treat adult patients with breast cancer where surgery is not possible or where the cancer has spread through the body, who have already received standard of care chemotherapy.
The shares slipped 15p or 0.2% to £109.2 and have fallen 18% over the last five months following a probe by Chinese authorities into allegations of importation of cancer drugs into the country without regulatory approval.
Over the weekend the Financial Times reported that AstraZeneca has overhauled senior management in China in an attempt to revive sales and draw a line under the recent scandals.
Today’s (20 Jan) announcement is the first approval in the US for AstraZeneca’s and partner Daiichi Sankyo’s antibody cancer drug Datroway and is based on positive results from the TROPION-Breast01 clinical study.
WHAT DID THE COMPANY SAY?
Executive vice president of AstraZeneca’s Oncology Haematology unit Dave Fredrickson commented: ‘With this first approval of Datroway in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers.
‘We are proud to bring Datroway to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.’
In the TROPION-Breast01 clinical study, Datroway demonstrated a significantly reduced risk of disease progression or death by 37%, compared with chemotherapy.
In the US more than 300,000 cases of breast are diagnosed each year. Survival rates are high for those diagnosed early but only about 30% of those where the cancer spreads are expected to live for five years following diagnosis.
Caitlin Lewis, Senior Vice President of Strategy & Mission, Living Beyond Breast Cancer, said: ‘The approval of Datroway is a significant advance, offering patients with metastatic HR-positive breast cancer a new and much-needed treatment option.’
