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 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 ]

Government Shutdown Impacts FDA Drug Approvals

FDA Approvals, News & Updates, In the News

Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. The FDA recently posted on its website a notice alerting the public of its current operational status. [ Read More ]

Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 21, 2018, the FDA accelerated the approval of venetoclax (Venclexta; AbbVie/Genentech), in combination with azacitidine (Vidaza), decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥75 years or those with comorbidities that preclude intensive induction chemotherapy. [ Read More ]

Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 16, 2018, the FDA approved brentuximab vedotin (Adcetris; Seattle Genetics), in combination with chemotherapy, for patients with untreated systemic ­anaplastic large-cell lymphoma (sALCL) or with other CD30-­expressing peripheral T-cell lymphomas (PTCLs), including angioim­munoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA-approved drug for newly diagnosed PTCL, including sALCL. Brentuximab vedotin was previously approved by the FDA for classical Hodg­kin lymphoma. [ Read More ]