Skip to NavigationSkip to content

FDA gives accelerated approval to AstraZeneca and Daiichi’s breast cancer drug

Published on 23/12/19 at 09:39am

The FDA has approved the breast cancer drug Enhertu, developed by AstraZeneca and Daiichi Sankyo.

José Basel, the Executive Vice President of Oncology Research & Development (R&D) at AstraZeneca, said: “With this first approval, we are proud to bring Enhertu to patients with high unmet need and we look forward to further exploring its potential in additional settings.”

It has been approved for the treatment of adult patients with breast cancer where the surgical removal of the affected area is not an option, or for the treatment of patients where the cancer is in a metastatic phase and they have received two or more prior anti-HER2 (human epidermal growth factor) based regimens in this setting.

The DESTINY-Breast01 trial for the drug enrolled 184 patients. The treatment shrank tumours in 60% of patients, with 4% achieving complete remission. Phase 3 trials are currently under way.

Antoine Yver, the Executive Vice President and global head of oncology R&D at Daiichi Sankyo, said: “The approval of Enhertu underscores that this specifically engineered HER2-directed antibody-drug conjugate is delivering on its intent to establish an important new treatment for patients with HER2-positive metastatic breast cancer.”

With this approval, AstraZeneca is obliged to pay Daiichi $125 million as a first milestone payment. Its overall licensing deal with Daiichi promised $5.6 billion, with $1.75 billion in payments tied to potential sales.

Breast cancer is the second most common cancer in women, after skin cancers. About 85% of breast cancers occur in women with no family history of the illness.

Conor Kavanagh

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches