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Enhertu Granted FDA Orphan Drug Designation for Gastric Cancer

AstraZeneca (NYSE: AZN) and Daiichi Sankyo Company, Limited (OTC: DSKYF)'s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

Benzinga · 05/22/2020 10:58

AstraZeneca (NYSE: AZN) and Daiichi Sankyo Company, Limited (OTC: DSKYF)'s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

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 US in 2020.1

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

In the Phase II DESTINY-Gastric01 trial, patients with HER2-positive metastatic gastric or gastroesophageal cancer who were treated with Enhertu, a HER2-directed antibody drug conjugate (ADC), demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, versus patients treated with investigator's choice of chemotherapy (irinotecan or paclitaxel monotherapy).

The overall safety and tolerability profile of Enhertu (6.4mg/kg) in DESTINY-Gastric01 was consistent with that seen in the Phase I gastric cancer trial. The most common adverse events were haematologic and gastrointestinal including neutrophil count decrease, anaemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were Grade 1 and 2, with two Grade 3 and one Grade 4. No Grade 5 events (ILD-related deaths) occurred in patients with gastric cancer in the Phase I trial or in the Phase II DESTINY-Gastric01 trial.

The full results of DESTINY-Gastric-01 will be presented during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020.

Earlier this month, Enhertu received two Breakthrough Therapy Designations for its potential use in HER2-positive unresectable or metastatic gastric cancer and HER2-mutant metastatic non-small cell lung cancer. Enhertu also received SAKIGAKE designation from Japan's Ministry of Health Labour and Welfare (MHLW) for potential use in HER2-positive gastric cancer in March 2018. A supplemental New Drug Application was recently submitted to the MHLW.