Article
Top news of the week from Specialty Pharmacy Times.
5. Nivolumab-Ipilimumab Combo Receives FDA Breakthrough Designation for Advanced Hepatocellular Carcinoma
FDA breakthrough designation is based on data for nivolumab plus ipilimumab in a study evaluating the immuno-oncology combination in patients with advanced hepatocellular carcinoma previously treated with sorafenib. Read more.
4. Teva to Resume Production of Vincristine After Widespread Shortages
With vincristine in short supply, Teva will resume production of the chemotherapy agent following its previous decision to remove the product from the market. Read more.
3. Intravenous Immunoglobulin Deemed Safe in Pediatric Patients
IVIG found to have a good safety profile in pediatric patients, with low risk of severe adverse drug reactions. Read more.
2. Zanubrutinib Granted Accelerated Approval for Second-Line Treatment of Mantle Cell Lymphoma
The FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for the treatment of mantle cell lymphoma in adults who have received at least 1 prior therapy. Read more.
1. Study: Ixekizumab Improves Symptoms of Non-Radiographic Axial Spondyloarthritis
The COAST-X study evaluated ixekizumab (Taltz, Eli Lilly) in patients with non-radiographic axial spondyloarthritis. Read more.
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a