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FDA approves Enhertu for HER2-low breast cancer

By Brian Buntz | August 5, 2022

AstraZeneca/Daiichi-Sankyo

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer.

Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype.

The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for metastatic cancer or if their cancer returned within 6 months of completing an adjuvant chemotherapy regimen.

Patients with low levels of the HER2 protein have traditionally had fewer treatment options than patients with HER2-positive breast cancer, according to the National Cancer Institute. Treatment options for such patients typically included endocrine therapy or chemotherapy.

Enhertu for HER2-low breast cancer

[Image courtesy of Daiichi-Sankyo/AstraZeneca]

Overall, about 2 million women per year are diagnosed with breast cancer.

FDA estimated that approximately 60% of patients with HER2-negative breast cancer qualify for the HER2-low designation.

AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY) jointly developed Enhertu.

To win the approval, the companies provided data from the Phase 3 DESTINY-Breast04 trial.

In April, Enhertu won Breakthrough Therapy designation from the FDA for HER2-low breast cancer, marking the fifth such designation for the drug.

In 2019, Enhertu first won FDA approval for some patients with HER2-positive unresectable or metastatic breast cancer. Two years later, the drug won an indication for previously treated HER2-positive advanced gastric cancer. Enhertu won approval in May 2022 for patients with HER2-positive metastatic breast cancer treated with an anti-HER2-based therapy.

On the London Stock Exchange, AstraZeneca shares were up 1.21% to £10,850.00. The company’s shares on the Nasdaq dipped 0.39% to $66.03.

Daiichi-Sankyo shares fared better, climbing 4.91% to $26.90. 

Earlier this year, AstraZeneca and Daiichi-Sankyo announced that Enhertu led to a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla). The study focused on second-line HER2-positive unresectable or metastatic breast cancer.

The companies also have a variety of other studies underway focused on Enhertu in breast, gastric and lung cancers. Studies are also underway for HER2-mutant tumors and HER2-expressing solid tumors.

 


Filed Under: Oncology
Tagged With: AstraZeneca, Daiichi Sankyo, Enhertu, Enhertu for HER2-low breast cancer, trastuzumab deruxtecan
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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