Enhertu Receives 2026 International Prix Galien Award for Best Biotechnology Product
Enhertu, a HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca, has received the 2026 International Prix Galien Award for Best Biotechnology Product. The recognition highlights the medicine’s contributions to cancer treatment and its impact on the development of innovative targeted therapies for patients with different types of HER2-expressing cancers.
The award is presented every two years by The Galien Foundation and recognizes outstanding achievements in biomedical innovation and medical technology. Enhertu’s latest recognition marks the second time the medicine has received a Prix Galien award, following its selection as the recipient of the 2024 Prix Galien USA Award for Best Biotechnology Product.
The 2026 International Prix Galien Award ceremony took place on Thursday, October 29, 2026, at the American Museum of Natural History in New York. Enhertu was selected as the winner from a group of six nominees in the Best Biotechnology Product category. The selection was made by an international committee comprising chairs representing the foundation’s member nations and participating regions.
The recognition reflects the scientific innovation behind Enhertu and its role in advancing treatment approaches for several cancer indications. Since its first approval in the United States in 2019, the medicine has contributed to changes in the treatment and classification of metastatic breast cancer, particularly through the establishment of HER2-low and HER2-ultralow breast cancer as clinically relevant patient segments.
Enhertu has also generated clinical results across early-stage and metastatic HER2-positive breast cancer, HER2-positive metastatic gastric cancer and HER2-positive solid tumors. Its development has expanded the application of HER2-directed treatment beyond traditional categories of HER2-positive disease, supporting new opportunities for targeted cancer therapy.
Second Prix Galien Recognition for Enhertu
The 2026 International Prix Galien Award represents another major recognition for Enhertu and the research and development efforts behind the medicine.
In 2024, Enhertu received the Prix Galien USA Award for Best Biotechnology Product. Under the foundation’s eligibility requirements, medicines that have received a National Prix Galien Award within the preceding two years may qualify for consideration for the International Prix Galien Award.
Enhertu was among six nominees evaluated for the 2026 international recognition. The award selection involved an international committee consisting of chairs from the participating member nations and regions, including Africa, Belgium/Luxembourg, Bridges, Canada, China, France, Germany, Greece, India, Italy, Japan, Korea, Poland, Switzerland, the Netherlands, the United Kingdom and the United States.
The international judging process recognizes biomedical and biotechnology innovations that demonstrate important contributions to human health. The award highlights scientific achievements with the potential to influence medical practice, improve treatment options and address significant healthcare challenges.
For Enhertu, the recognition reflects its development as a targeted cancer medicine and its expanding clinical role across multiple tumor types.
The medicine uses antibody drug conjugate technology to deliver a cytotoxic payload to cancer cells expressing the HER2 protein. This approach combines the targeting capabilities of an antibody with the cancer-killing activity of a chemotherapy payload, providing a mechanism designed to deliver treatment more selectively to tumor cells.
The award also recognizes the work of the scientific teams responsible for developing the underlying DXd ADC technology and advancing its clinical applications.
Enhertu’s Role in Transforming HER2-Directed Cancer Treatment
Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
HER2, or human epidermal growth factor receptor 2, is a protein involved in cell growth and division. In certain cancers, HER2 expression or gene amplification can contribute to tumor development and progression.
HER2 has become an important therapeutic target in oncology, particularly in breast and gastric cancers. However, the level of HER2 expression can vary between tumor types and individual patients, creating different opportunities for targeted treatment.
Traditional HER2-directed treatment approaches have primarily focused on cancers with high levels of HER2 expression. However, research supporting Enhertu has contributed to a broader understanding of the potential role of HER2 as a therapeutic target.
Since its initial US approval in 2019, Enhertu has helped establish HER2-low and HER2-ultralow metastatic breast cancer as clinically distinct patient segments that may benefit from HER2-directed antibody drug conjugate treatment.
This development has been important because patients with lower levels of HER2 expression were historically not considered eligible for certain HER2-targeted treatment approaches.
Enhertu’s clinical development has demonstrated the potential to extend targeted treatment opportunities to additional breast cancer populations. Its application across different HER2 expression categories has contributed to changes in the way certain forms of breast cancer are classified and treated.
The medicine’s development has also extended beyond breast cancer. Clinical research has generated additional results in HER2-positive metastatic gastric cancer and other HER2-positive solid tumors.
According to Daiichi Sankyo, Enhertu has delivered a series of practice-changing clinical results across early-stage and metastatic settings of HER2-positive breast cancer, as well as HER2-positive metastatic gastric cancer.
These developments demonstrate the expanding clinical applications of the medicine and the potential of antibody drug conjugate technology to address different cancer indications.
DXd Antibody Drug Conjugate Technology Behind Enhertu
A central component of Enhertu’s development is Daiichi Sankyo’s proprietary DXd antibody drug conjugate technology.
Antibody drug conjugates are designed to combine the targeting specificity of monoclonal antibodies with the cancer-killing activity of cytotoxic agents. These medicines use an antibody to recognize and bind to a particular protein expressed on cancer cells.
Following binding and internalization into the target cell, the ADC can release its cytotoxic payload, which is intended to damage cancer cells and interfere with their survival.
Enhertu incorporates a HER2-directed antibody linked to a topoisomerase I inhibitor payload through a specialized linker. This design allows the medicine to target HER2-expressing cancer cells and deliver its cytotoxic component.
The DXd platform represents an important part of Daiichi Sankyo’s oncology research strategy. Through the development of this technology, the company aims to create additional antibody drug conjugates targeting different cancer-associated proteins.
Enhertu’s clinical development has demonstrated the potential of this approach across several cancer settings, while its expanding indications illustrate the importance of continued research into targeted drug delivery technologies.
The development of ADCs has become an important area of oncology innovation, particularly as researchers seek approaches that combine targeted delivery with effective anticancer activity.
Daiichi Sankyo’s work on DXd technology has contributed to the advancement of this therapeutic category and provided the scientific foundation for Enhertu.
First HER2-Directed Tumor-Agnostic Medicine for HER2-Positive Solid Tumors
Another significant development highlighted by Daiichi Sankyo is Enhertu’s role as the first HER2-directed tumor-agnostic medicine for HER2-positive solid tumors.
A tumor-agnostic treatment approach is designed to target a specific molecular characteristic or biomarker rather than being restricted to the anatomical location where a cancer originates.
This approach represents an important development in precision oncology because certain molecular abnormalities can occur across different cancer types.
By focusing on HER2 as a therapeutic target, Enhertu’s tumor-agnostic development provides an additional treatment approach for eligible patients with HER2-positive solid tumors, regardless of the primary tumor location, subject to the applicable regulatory indication and eligibility requirements.
This development further illustrates the potential of biomarker-driven treatment strategies to expand therapeutic options across oncology.
The medicine’s clinical and regulatory progress across different cancer types also demonstrates how targeted therapies can contribute to more individualized approaches to cancer treatment.
Daiichi Sankyo Highlights Scientific Innovation Behind Enhertu
Hiroyuki Okuzawa, president and chief executive officer of Daiichi Sankyo, expressed appreciation for the international recognition and highlighted the medicine’s contributions to cancer treatment.
“We are honored to receive this second Prix Galien award, which recognizes the impressive advances Enhertu has made possible for certain patients with cancer around the world. Since its first US approval in 2019, Enhertu has transformed the treatment and classification of metastatic breast cancer by pioneering the establishment of HER2 low and HER2 ultralow breast cancer as clinically distinct patient segments,” Okuzawa said.
He also highlighted the medicine’s clinical achievements across different cancer settings, including early-stage and metastatic HER2-positive breast cancer and HER2-positive metastatic gastric cancer.
According to Okuzawa, Enhertu has delivered several important clinical results that have influenced treatment standards and expanded the potential applications of HER2-directed therapy.
He further emphasized the significance of Daiichi Sankyo’s scientific contribution to the development of the DXd antibody drug conjugate technology.
The company is particularly proud of the work undertaken by its scientists in developing the technology behind Enhertu and intends to build on these achievements through continued research and development.
“We are extremely proud that scientists at Daiichi Sankyo invented the DXd antibody drug conjugate technology behind Enhertu, and we look to continue this important work through the development of additional breakthrough medicines for cancer,” Okuzawa added.
The company’s commitment to expanding its ADC research reflects its broader oncology strategy, which focuses on developing innovative medicines for patients with cancer and addressing areas of significant unmet medical need.
The Galien Foundation Recognizes Global Biomedical Innovation
The International Prix Galien Award is presented by The Galien Foundation, an organization dedicated to fostering, recognizing and rewarding excellence in scientific innovation aimed at improving human health.
The foundation’s vision is to serve as a catalyst for developing the next generation of medicines and technologies that have the potential to transform medical practice and save lives.
The Prix Galien was established in France in 1970 by pharmacist Roland Mehl in honor of Galen, who is widely recognized as a foundational figure in medical science and modern pharmacology.
Over the years, the award has developed into one of the most recognized international honors in the biopharmaceutical and healthcare innovation industries.
It is widely regarded as the equivalent of the Nobel Prize in biopharmaceutical research because of its focus on recognizing important scientific achievements and innovations that contribute to human health.
The awards recognize outstanding biomedical and medical technology products that demonstrate meaningful contributions to healthcare.
The International Prix Galien selection process involves an international committee representing participating national and regional Prix Galien organizations. The committee evaluates eligible products and recognizes innovations that have demonstrated significant scientific and medical contributions.
The 2026 ceremony at the American Museum of Natural History in New York brought together the international scientific and healthcare innovation community to recognize achievements in biomedical research and product development.
Enhertu’s selection as the 2026 Best Biotechnology Product highlights the importance of continued investment in innovative cancer medicines and the development of technologies capable of addressing complex diseases.
AstraZeneca and Daiichi Sankyo Continue Joint Development Efforts
Enhertu was discovered by Daiichi Sankyo and is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The collaboration combines the companies’ research and development capabilities, oncology expertise and global development resources to advance the medicine across multiple cancer indications.
Since its first US approval in 2019, Enhertu has progressed through an expanding clinical development program, generating evidence across different HER2 expression levels and tumor types.
The collaboration has supported the investigation of the medicine in early-stage and metastatic breast cancer, gastric cancer and other solid tumors.
Its expanding clinical profile reflects the companies’ efforts to explore additional opportunities for HER2-directed ADC treatment and improve therapeutic options for eligible patients.
The recognition from The Galien Foundation also highlights the scientific and commercial importance of collaboration in advancing complex biotechnology products from discovery through clinical development and commercialization.
Continuing Innovation in Antibody Drug Conjugates
The 2026 International Prix Galien Award adds another milestone to Enhertu’s development history and recognizes its contribution to advances in targeted cancer treatment.
The medicine’s clinical progress has helped broaden the understanding of HER2-directed therapy, particularly in metastatic breast cancer populations with lower levels of HER2 expression.
Its development across multiple cancer indications also demonstrates the potential of DXd antibody drug conjugate technology to support new treatment approaches in precision oncology.
For Daiichi Sankyo and AstraZeneca, the recognition reinforces the importance of continued innovation in oncology and the development of medicines targeting specific biological characteristics of cancer cells.
As research continues, the companies aim to build on the scientific foundation established by Enhertu and advance additional innovative cancer therapies.
The second Prix Galien recognition represents an acknowledgment of the work undertaken by the scientists, researchers and clinical development teams involved in bringing Enhertu to patients.
With its expanding clinical applications and established role in several HER2-directed treatment settings, Enhertu remains an important example of how antibody drug conjugate technology can contribute to the evolution of cancer treatment and the advancement of precision medicine.
About Enhertu
Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US only) is a HER2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Enhertu (5.4 mg/kg) followed by THP is approved in more than five countries/regions worldwide as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial.
Enhertu (5.4 mg/kg) is approved in more than 35 countries/regions worldwide for the adjuvant treatment of adults with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.
Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.
Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.
Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, which have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.
Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.
Enhertu (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04trials.
Enhertu (5.4 mg/kg) is approved in more than 50 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
About the Enhertu Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.
About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.