FDA Approvals, News & Updates

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 Second Indication for Keytruda in the Treatment of Melanoma

March 2019, Vol 9, No 3 - FDA Approvals, News & Updates, Melanoma

On February 15, 2019, the FDA approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of melanoma with involvement of lymph node(s) after a complete resection. This is the second melanoma-related indication for pembrolizumab, which was previously approved by the FDA for the treatment of patients with unresectable or metastatic melanoma. [ Read More ]

Imbruvica plus Gazyva Approved as First-line Treatment for CLL/SLL

March 2019, Vol 9, No 3 - FDA Approvals, News & Updates, Leukemia, Lymphoma

On January 28, 2019, the FDA approved the combination of ibrutinib (Imbruvica; Pharmacyclics), an oral Bruton’s tyrosine kinase inhibitor, plus obinutuzumab (Gazyva; Genentech), a CD20-directed cytolytic antibody, for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Imbruvica has been previously approved as a single agent for the treatment of adults with CLL or SLL, including those with 17p deletion [del(17p)]. [ 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 ]