Web Exclusives
On August 2, 2019, the FDA approved pexidartinib (Turalio; Daiichi Sankyo) capsules, a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor (TGCT), which is associated with severe morbidity or functional limitations, who are not candidates for surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT. The FDA granted pexidartinib a priority review and breakthrough therapy and orphan drug designations. Read More ›
On August 15, 2019, the FDA accelerated the approval of entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, for the treatment of adults and adolescents whose cancer involves neurotrophic tyrosine receptor kinase (NTRK) gene fusion that has no effective treatments. The FDA granted entrectinib a priority review and breakthrough therapy and orphan drug designations. This is the third cancer drug approved by the FDA based on a common biomarker and the second drug for patients with NTRK gene fusion. Read More ›
By Phoebe Starr
Barcelona, Spain—Late-breaking data from 2 clinical trials presented at ESMO 2019 will likely change the treatment paradigm for pre- or postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer, regardless of menopausal status. The MONALEESA-3 study and the MONARCH-2 study showed an improved overall survival (OS) with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) or abemaciclib (Verzenio) to endocrine therapy as first- or second-line therapy. The results were presented at the Presidential Session of the meeting. Read More ›
San Francisco, CA—The increasing rate of infection with the human papillomavirus (HPV) in the United States has changed the field of head and neck cancer, or oral cancer, and HPV infection now causes a growing majority (70%-90%) of oropharyngeal squamous-cell carcinomas. As its incidence is rising, so is patients’ curiosity about what sets this cancer apart from other malignancies. Read More ›
- Zejula Now Approved for Late-Line Ovarian Cancer
- Trump Set to Nominate Hahn as FDA Commissioner
- FDA Aims to Improve Breast Implant Guidance
The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer. Read More ›
FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines. Read More ›
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review. Read More ›
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 ›
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 ›