August 6, 2022

Enhertu® (fam-trastuzumab deruxtecan-nxki) has won FDA approval to treat unresectable or metastatic HER2-low breast cancer in adults who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

  • This is the first FDA approved targeted therapy for HER2-low metastatic breast cancer.
  • First FDA approved in 2019, Enhertu is also indicated to treat certain adults who have HER2- positive breast cancer or HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  • Recommended dosing for breast cancer is 5.4mg/kg of the patient’s body weight given as an intravenous infusion once every three weeks until disease progression or unacceptable toxicity occur.
August 18, 2022

U.S. FDA Approves First Cetrotide Generic

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August 17, 2022

Zynteglo Approved as Gene Therapy for Rare Blood Disorder

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