Top news of the week from Specialty Pharmacy Times.
5. Bemcentinib Receives FDA Fast Track Designation for Elderly Patients With Relapsed AML
Officials with the FDA have granted fast track designation to BerGenBio’s bemcentinib for the treatment of elderly patients with acute myeloid leukemia (AML) whose disease has relapsed. Read more.
4. Amgen Set to Make Repatha Available Exclusively at Lower List Price Option
By 2020, Amgen’s evolocumab (Repatha) will be available exclusively at a 60% price reduction from its annual list price of $14,100 to a cost of $5850. Read more.
3. FDA OKs Niraparib for Patients with HRD-Positive Advanced Ovarian Cancer
The FDA approved niraparib (Zejula, Tesaro) for the treatment of patients with advanced homologous recombination deficiency (HRD)-positive status ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or more prior chemotherapies. Read more.
2. FDA Approves Ustekinumab for Patients with Acute Ulcerative Colitis
The FDA has approved ustekinumab (Stelara, Janssen) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). Read more.
1. First Triple Combo Therapy Approved for Cystic Fibrosis in Adults, Adolescents with F508del Mutation
The FDA today approved elexacaftor/ivacaftor/tezacaftor (Trikafta, Vertex Pharmaceuticals), a new treatment for patients 12 years of age and older with cystic fibrosis (CF) who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read more.