The US Food and Drug Administration (FDA) accepted for review AstraZeneca and Daiichi Sankyo’s biologics license application (BLA) under priority review for trastuzumab deruxtecan.
The biologic is an antibody drug conjugate (ADC), for which AZ was prepared to pay up to $6.9bn (€6.2bn) to partner with Daiichi Sankyo earlier this year.
A decision on the treatment will be made in the second quarter of 2020 regarding the biologic’s use in the treatment of HER2-positive metastatic breast cancer.
The drug candidate supplied data from Phase I and Phase II trials to support the application, whilst there are five ongoing trials underway that also include using the ADC as a treatment for advanced colorectal cancer and non-small cell lung cancer.
Outside of the US, a regulatory filing has already been submitted to Japanese authorities, where Daiichi Sankyo is solely responsible for commercialization. In addition, the company is also responsible for the manufacture and supply of the drug in the country.
As more ADCs move through the pipeline, contract development and manufacturing organizations (CDMOs) have been preparing facilities for commercial scale production, including WuXi Biologics and Lonza. The latter company is currently responsible for the commercial manufacture for three of the five approved ADCs on the market.