FDA Updates

• 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

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.

• 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

• Zejula Now Approved for Late-Line Ovarian Cancer
• Trump Set to Nominate Hahn as FDA Commissioner
• FDA Aims to Improve Breast Implant Guidance