JHOP Web Exclusives
FDA Implements New Steps to Encourage Generic Drug Competition, Expand Patients’ Access to Inexpensive Medicines
FDA Commissioner Scott Gottlieb, MD, announced new steps as part of the FDA’s Drug Competition Action Plan to promote generic drug competition as a way to expand potential access to inexpensive medicines, which would be especially helpful for patients with cancer.
On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg; Pfizer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML. It is approved as an orphan drug for this indication.
On July 31, 2017, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with mismatch repair–deficient (dMMR) and microsatellite instability–high (MSI-H) metastatic colorectal cancer (CRC) that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfizer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval.
Kymriah First Gene Therapy Approved by the FDA, Indicated for Young Patients with B-Cell ALL and CD19
On August 30, 2017, the FDA approved tisagenlecleucel (Kymriah; Novartis Pharmaceuticals), a genetically modified chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of pediatric patients and young adults aged ≤25 years with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
- Enasidenib, a New Targeted Therapy Approved for Relapsed or Refractory AML
- Ibrutinib First Treatment Approved by the FDA for Chronic Graft-versus-Host Disease
- Vyxeos First Treatment Approved Specifically for 2 Types of High-Risk AML
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Results 1 - 10 of 20
Results 1 - 10 of 20