FDA News & Updates
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.
Read More ›- Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
- 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
- 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
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between September 17 and September 26, 2019. Read More ›
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review. Read More ›
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 ›
- 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 ›