This week on the Pod: The FDA issues guidance for COVID-19 vaccine development; Accuracy in COVID-19 antibody testing; How statins may improve outcomes for hospitalized COVID-19 patients; and in non-COVID-related news there’s a new drug approvals in breast cancer and Dravet syndome.
The FDA has approved Phesgo™ (pertuzumab, trastuzumab, hyaluronidase-zzxf; Genentech), in combination with chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.
This month we look at a case where the jury ultimately decided for the defendant physician who was sued by a former patient after she developed cardiomyopathy from a medication prescribed by the physician.
This slideshow shows drug information for Trodelvy. Click here for the complete Trodelvy monograph.
Immunomedics announced the availability of Trodelvy™ (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate to get FDA approval for this indication. Trodelvy is administered via intravenous infusion after reconstitution and dilution. Premedication…
This slideshow shows drug information for Tukysa. Click here for the complete Tukysa monograph.
The FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy; Immunomedics) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.
The FDA has approved Tukysa (tucatinib; Seattle Genetics), in combination with trastuzumab and capecitabine, for treatment of adult patients with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, including patients with brain metastases, who have received 1 or more prior anti-HER2-based regimens in the metastatic setting.
Ontruzant is supplied in 150 mg single-dose vials and 420 mg multidose vials.
The FDA has approved a 420mg multidose vial of Ontruzant (trastuzumab-dttb; Samsung Bioepis), a biosimilar to Herceptin (trastuzumab; Genentech), adding to the 150mg single-dose vial originally approved in January 2019.
