This should come as a relief for the U.K. pharma giant, which recently flunked a late-stage non-small cell lung cancer study.
AstraZeneca and Daiichi Sankyo said the FDA has accepted for review the BLA for trastuzumab deruxtecan, granting the application priority review status.
ADCs are a class of drugs that are considered a targeted therapy for treating cancer. They consist of a monoclonal antibody chemically linked to a drug.
AstraZeneca entered a collaboration agreement with Daiichi Sankyo for developing trastuzumab deruxtecan in March by making an upfront payment of $1.35 billion. Additionally, Daiichi Sankyo is eligible to receive contingent payments up to $5.55 billion as well as $1.75 billion for sales-related milestones.
AstraZeneca also acquired worldwide commercialization rights to the ADC candidate, except in Japan.
Why It's Important
HER2-positive cancer is a type of cancer which tests positive for a protein called human epidermal growth factor receptor 2, or HER2, found on the surface of some cancer cells. They are associated with aggressive disease and poorer prognosis.
About one in five breast cancers are HER-2 positive.
Despite recent improvements and approvals of medicines, a significant clinical need remains for patients with advanced HER2-positive metastatic breast cancer, according to AstraZeneca.
Trastuzumab deruxtecan already has a Breakthrough Therapy Designation and Fast Track designation from the FDA.
The priority review status reduces the review period from the standard 10 months to six months.
The PDUFA date for the trastuzumab deruxtecan has been set for the second quarter of 2020.
AstraZeneca shares were 0.73% higher at $44.11 at the time of publication Thursday.
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