Enhertu (Trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody and a cytotoxic topoisomerase I inhibitor. Three components create this antibody-drug conjugate (ADC):
- A topoisomerase inhibitor (TI) that is covalently linked to,
- Humanized anti-HER2 IgG1 monoclonal antibody (mAb) via,
- Tetrapeptide-based cleavable linker
Recombinant DNA technology (rDNA) is used to develop the antibody in CHO cells (stands for Chinese hamster ovary cells), and chemical synthesis is used to develop the topoisomerase inhibitor (TI) and linker. Each antibody molecule is joined to around 8 molecules of deruxtecan.
Enhertu is not (yet) approved in India so its price is not fixed. Patients can buy Enhertu online in India under the provision Named Patient Program (NPP). The medication is commercially available in 100 mg vials in the international pharmaceutical markets.
In August 2022, Enhertu (trastuzumab deruxtecan) was authorized to treat patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating mutations HER2, as per a joint statement from AstraZeneca (AZ) and Daiichi Sankyo. As per the fast approval pathway, the Food and Drug Administration approved the medicine on behalf of the objective response rate (ORR) of 57.7% and the length of response demonstrated in clinical trials.
With this, the agency FDA has now approved Enhertu 100 mg injection for treating 3 different types of tumors. While, in 2021, the medicine was approved for stomach or gastric cancer and became the first HER2-directed drug in the past 10 years approved by the Food and Drug Administration to treat stomach or gastric cancer.
Milestone of Enhertu:
A confirmed overall response rate (ORR) of 72.7% in 11 patients with extensively pretreated HER2 mutant NSCLC was noticed in an updated subgroup evaluation from an ongoing phase-I study of Enhertu (NSCLC).
Given the unmet medical requirement for patients with metastatic non-small cell lung cancer (NSCLC) with mutations HER2 who have advanced on several previous treatments, the preliminary results noticed with Enhertu were encouraging. The results also present that patients with non-small cell lung cancer (NSCLC) should continue to assess treatments that specifically target the HER2 receptor.
Enhertu (Trastuzumab deruxtecan) is one of a class of treatments known as antibody-drug conjugates (ADCs), which attach monoclonal antibodies to tumor cells with a “linker” to have a generally more focused and promising effect on cancer. The medicinal product was developed collaboratively by AstraZeneca (AZ) and Daiichi Sankyo. With its precise target technique, the drug was granted different designations for its expedited approval in several countries for the management of cancer. Besides, this medication has now received approval for 3 distinct tumor types, which demonstrates its substantial potential for use in different HER2-targetable tumors. Apart from these, the medicine Enhertu 100 mg is under development which mainly includes Phase-II development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC, HER2 expressing advanced colorectal cancer, and Phase-I development in conjunction with the drug nivolumab for HER2 expressing metastatic breast cancer and bladder cancer.