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Daiichi Sankyo/AstraZeneca’s ENHERTU Granted Orphan Drug Designation

Daiichi Sankyo, with offices in Basking Ridge, and AstraZeneca have been granted Orphan Drug Designation (ODD) in the US for ENHERTU®, a treatment for patients with gastric cancer, including gastroesophageal junction cancer.

In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for the manufacturing and supply.

The U.S. Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases of disorders that affect fewer than 200,000 people in the U.S.

An estimated 27,600 new cases of gastric cancer will be diagnosed this year, and the disease could lead to more than 11,000 deaths in the U.S. in 2020.1

ENHERTU is a HER2 directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC Scientific platform.

The drug is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2 based regimens based on the DESTINY-Breast01 trial. ENHERTU has been approved for use only in the U.S. and Japan.

A comprehensive development program for ENHERTU is underway globally with six pivotal trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

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