In the News

Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer

Yvette Florio Lane

FDA Approvals, News & Updates, In the News

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases. [ Read More ]

First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL

FDA Approvals, News & Updates, In the News

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 at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation. [ Read More ]

FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

Breast Cancer, FDA Approvals, News & Updates, In the News

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 FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay). [ Read More ]

Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation

FDA Approvals, News & Updates, In the News

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 comorbidities that preclude the use of intensive induction chemotherapy. [ Read More ]

FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer

Breast Cancer, FDA Approvals, News & Updates, In the News

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 therapy to be approved for men. [ Read More ]

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 ]