FDA Approvals, News & Updates
The Lynx Group is pleased to bring you the Third Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new hematology oncology drugs approved by the US Food and Drug Administration (FDA) in 2017.
In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high. In addition to these impressive approvals, the first-ever 3 gene therapies were also approved.
On April 28, 2017, the FDA accelerated the approval of brigatinib (Alunbrig; Takeda Oncology), a new-generation oral ALK inhibitor, for the treatment of patients with ALK-positive metastatic NSCLC who do not tolerate or have had an inadequate response to crizotinib.
On October 31, 2017, the FDA granted an accelerated approval for acalabrutinib (Calquence; AstraZeneca), an oral BTK inhibitor, for the treatment of adults with mantle-cell lymphoma who have received at least 1 therapy.
Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease
On January 19, 2017, the FDA granted accelerated approval of a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with relapsed or refractory MZL who require systemic therapy after at least 1 anti-CD20–based therapy.
Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer
On May 1, 2017, the FDA granted accelerated approval to durvalumab (Imfinzi; AstraZeneca), an intravenous (IV) PD-L1 inhibitor, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer
On March 13, 2017, the US Food and Drug Administration (FDA) approved ribociclib (Kisqali; Novartis), an oral CDK4/CDK6 inhibitor, in combination with letrozole for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.
Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy
On August 30, 2017, the US Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah; Novartis), a CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of patients aged ≤25 years with B-cell precursor ALL that is refractory, in second relapse, or later relapse.
Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma
On February 22, 2017, the US Food and Drug Administration (FDA) approved lenalidomide (Revlimid; Celgene), an oral IMiD, for maintenance therapy after autologous HSCT in patients with multiple myeloma.
Page 1 of 3
Results 1 - 10 of 23
Results 1 - 10 of 23