FDA approves Enhertu for HER2-low breast cancer

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 is now the first approved therapy for patients with 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.

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

FDA estimated that approximately 60% of patients with…

Read more
  • 0

Enhertu slashed risk of disease progression or death by half compared to chemotherapy HER2-low breast cancer

AstraZeneca (LON:AZN) and Daiichi Sankyo’s (OTCMKTS:DSNKY) Enhertu (fam-trastuzumab deruxtecan-nxki) showed a dramatic survival benefit in the pivotal DESTINY-Breast04 Phase 3 study focused on a subset of breast cancer patients. The DNA topoisomerase I inhibitor improved median overall survival by more than six months compared to chemotherapy in the study. In addition, the drug met the primary endpoint of progression-free survival in the study, cutting the risk of disease progression or death by 49% compared to chemotherapy.

AstraZeneca reports that the therapy could potentially redefine treatment for roughly half of breast cancer patients.

The DESTINY-Breast04 study focused on previously-treated patients with HER2-low unresectable or metastatic breast cancer.

AstraZeneca notes that Enhertu is the first HER2-focused therapy to show a survival benefit in the patient demographic.

Enhertu met the primary endpoint of progression-free survival in patie…

Read more
  • 0

AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA.

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

The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.

Of the five breakthrough therapy designations for the drug, three are for breast cancer, while the other two are in lung and gastric cancers, respectively.

In particular, the designation covers adults who have received prior systemic therapy for metastatic breast cancer or who have experienced disease recurrence within six months of finishing adjuvant chemotherapy.

In addition, the designation specifies that patients with hormone receptor (HR) positive breast cancer have received or be inelig…

Read more
  • 0