In the News

FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

FDA Approvals, News & Updates, In the News

On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer. [ Read More ]

FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma

Drug Updates, FDA Approvals, News & Updates, In the News

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion. [ Read More ]