On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after [ Read More ]
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an [ Read More ]
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have [ Read More ]
On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. This application was granted [ Read More ]
In This Article FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) On April 11, 2019, the US Food and [ Read More ]
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based [ Read More ]
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services. Currently, under the Mammography Quality Standards Act, which [ Read More ]
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq. On March 18, 2019, the FDA awarded the immunotherapy agent, Tecentriq (atezolizumab; Genentech), in combination with chemotherapy (carboplatin and etoposide), approval for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC). [ Read More ]
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 [ Read More ]
Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
