FDA Approvals, News & Updates
- Teva Will Resume Production of Vincristine in Response to Shortage
- FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
- FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
On September 17, 2019, the FDA approved a new indication for apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication. Read More ›
On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation. Read More ›
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of multiple myeloma in patients eligible for autologous stem-cell transplant (ASCT). In June 2019, the FDA approved the combination of daratumumab plus lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT. The FDA granted this application a priority review. Read More ›
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 ›