AstraZeneca Receives FDA Priority Review For Breast Cancer Drug

In Clinical Studies News by Barbara Jacoby

Source: AstraZeneca


AstraZeneca have announced that the US FDA has granted Priority Review for its experimental breast cancer treatment trastuzumab.

The Prescription Drug User Fee Fact (PDUFA) date for trastuzumab deruxtecan, an HER-2 targeting antibody drug conjugate and potential new medicines for the treatment of HER2-positive metastic breast cancer is set for the second quarter of 2020.

José Baselga, Executive Vice President of Oncology and R&D at AstraZeneca, said: Trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options today. This Priority Review draws on the strength and the consistency of results seen in the Phase I and Phase II trials and is a critical step on the journey to deliver this potential new medicine to patients.”

The drug itself is part of a collaboration with Japan’s Daiichi Sankyo in which it was agreed AstraZeneca would pay Daiichi upto $6.9 billion to work on the treatment. It is in direct challenge to the world’s biggest cancer drug manufacturer Roche.

The treatment itself, also known as DS-8201, targets the HER2 protein, a major trigger in uncontrolled cell growth in about 20% of breast cancer cancers and is an area where Roche has been a pioneer with its top-seller Herceptin.

Antoine Yver, Executive Vice President at Daiichi Sankyo, added: “We are pleased that the FDA has accepted the application and granted Priority Review, as we believe trastuzumab deruxtecan has the potential to redefine the treatment of patients with HER2-positive metastatic breast cancer. Following the recent regulatory submission in Japan, we look forward to working closely with regulatory authorities to bring trastuzumab deruxtecan to patients in the US and Japan as soon as possible.”

Trastuzumab deruxtecan was previously granted US FDA Breakthrough Therapy and Fast Track Designation which was based on the combination of data from the phase 1 trial published in the The Lancet Oncology as well as the pivotal Phase II DESTINY-Breast01 trial.

Detailed data from DESTINY-Brest01 will be presented at the forthcoming San Antonio Breast Cancer Symposium in December.