FDA Approvals, News & Updates
The Value of Pre–FDA Approval Healthcare Economic Information Exchange Between Payers and Drug Manufacturers
Adoption of healthcare economic information communication could improve formulary decision-making and increase patient access to drugs, suggest Peter R. Fendt, PharmD, MBA, and colleagues.
- Lynparza First Treatment Approved for Patients with Germline BRCA-Positive Metastatic Breast Cancer
- Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations
- Lutathera First Radioactive Drug Approved for Adults with Gastroenteropancreatic Neuroendocrine Tumors
- Zytiga Receives New Indication, with Prednisone, for Metastatic, High-Risk Castration-Sensitive Prostate Cancer
- Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer
- Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation
In association with the approval of the first chimeric antigen receptor (CAR) T-cell therapy, on August 30, 2017, the FDA also accelerated the approval of a new indication as an orphan drug for tocilizumab.
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).
On August 17, 2017, the FDA approved a new indication for olaparib, in tablet form, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease completely or partially responded to chemotherapy that was platinum-based, regardless of their BRCA mutation status.
- 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 21 - 30 of 138
Results 21 - 30 of 138