FDA Approvals, News & Updates
On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment of patients with advanced homologous recombination deficiency (HRD)-positive ovarian, fallopian tube, or primary peritoneal cancer who have received ≥3 previous lines of chemotherapy. The FDA used its priority review program for this approval. Read More ›
- FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
- Trump Will Nominate Dr Hahn as Next FDA Commissioner
- Researchers Report High Rates of E-Cigarette Use Among Children and Teens
- Zejula Now Approved for Late-Line Ovarian Cancer
- Trump Set to Nominate Hahn as FDA Commissioner
- FDA Aims to Improve Breast Implant Guidance
Breast Cancer, FDA Approvals, News & Updates, Multiple Myeloma, Pediatric Cancers, In the Literature
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 Approvals, News & Updates, National Comprehensive Cancer Network (NCCN), NCCN Guideline Updates, In the Literature
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 August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene) for the treatment of patients with intermediate-2 or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis. 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 ›
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
Read More ›On August 15, 2019, the FDA granted accelerated approval to entrectinib (Rozlytrek; Genentech) for the treatment of patients aged ≥12 years with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed after treatment or have no satisfactory standard therapy.
Read More ›On June 10, 2019, the FDA accelerated the approval of polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar; BR) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 previous therapies. Read More ›