Enhertu wins two FDA breakthrough therapy designations

31 Aug 2023
www.pharmaceutical-technology.com
Clinical ResultASCODrug ApprovalBreakthrough TherapyPhase 2
Enhertu wins two FDA breakthrough therapy designations
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Source: Pharmaceutical Technology
Robert Barrie
Enhertu wins two FDA breakthrough therapy designations
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Source: Pharmaceutical Technology
The ADC is already approved in different settings for patients with breast cancer, non-small cell lung cancer and gastroesophageal junction adenocarcinoma. Image credit: Shutterstock/Christoph Burgstedt.
The anti-cancer drug Enhertu is going from strength to strength in 2023 after the US Food and Drug Administration (FDA) granted two additional breakthrough therapy designations to the therapy.
Daiichi Sankyo and AstraZeneca are jointly developing and commercialising Enhertu (fam-trastuzumab deruxtecan-nxki), a human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC). With the latest news, the drug now has seven breakthrough designations to date.
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The ADC is approved in different settings for patients with breast cancer, non-small cell lung cancer and gastroesophageal junction adenocarcinoma. One of the two most recent designations is not limited to a particular type of cancer but is for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumoursHER2-positive solid tumours that are not responding to treatment and who have no satisfactory alternative treatment options, signifying its pan-tumour potential.
In July 2023, the companies reported positive data from a Phase II trial, demonstrating clinically meaningful survival rates in patients across multiple HER2-expressing advanced solid tumoursHER2-expressing advanced solid tumours – including those found in biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers. The interim analysis of the DESTINY-PanTumor02, which was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, showed Enhertu shrank tumours in 37.1% of patients in the trial.
Reacting to the results announced at the 2023 ASCO, former GlobalData senior oncology and haematology analyst Avigayil Chalk commented: “Tumour-agnostic approval would lead to increased sales for Enhertu, which already achieved blockbuster status in 2022, with global sales exceeding $1.6bn.
“GlobalData’s consensus forecast projects global sales for Enhertu to exceed $9.9bn by 2029, driven by increased uptake for already approved indications across markets and expansion into new indications.”
The second designation is for the treatment of patients with HER2-positive metastatic colorectal cancerHER2-positive metastatic colorectal cancer who have received two or more prior regimens.
AstraZeneca’s oncology R&D executive vice-president Susan Galbraith said: “This is an important step in bringing Enhertu to patients with a broad range of HER2 expressing solid tumours who currently face a poor prognosis.”
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