2018 Third Annual Oncology Guide to New FDA Approvals
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
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.
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