Web Exclusives | June 26, 2019
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.
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
Web Exclusives | June 12, 2019
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.
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
Web Exclusives | May 14, 2019
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).
Web Exclusives | May 7, 2019
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.
Web Exclusives | April 23, 2019
Another Approval for Keytruda
Web Exclusives | April 5, 2019
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.
Web Exclusives | April 1, 2019
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.
FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
Web Exclusives | March 22, 2019
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Web Exclusives | March 15, 2019
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.
Web Exclusives | February 22, 2019
On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
Web Exclusives | February 19, 2019
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.
Web Exclusives | October 2, 2018
The Academy of Oncology Nurse & Patient Navigators (AONN+) is pleased to announce Dr Jill Biden as the Keynote Speaker for the Ninth Annual Navigation & Survivorship Conference.
Quizartinib Significantly Improves Survival Over Chemotherapy in Patients with Relapsed/Refractory AML and FLT3-ITD Mutation
Web Exclusives | May 15, 2018
These results make quizartinib the first FLT3 inhibitor to demonstrate such improvement over chemotherapy in this patient population.
Breaking News: Sellas Announces Promising Data on NeuVax in Combination with Herceptin in HER2 1+/2+ Breast Cancer
Web Exclusives | April 7, 2018
NeuVax + Herceptin may provide a clinically meaningful benefit to breast cancer patients with low to intermediate HER2-expression.
With Emerging Oncology Therapies and Rising Patient Responsibilities, Financial Navigation Will Have a Greater Role in Cancer Care
Web Exclusives | January 18, 2018
Emerging pharmacologic therapies used for the treatment of oncology are being developed and approved at an accelerated rate.
Web Exclusives | April 17, 2017
AONN+ Navigation Metrics can be incorporated into partnerships between oncology patient navigators and physician practices.
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