In the Literature
Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity. Read More ›
In This Article:
- FDA approves Lonsurf (trifluridine/tipiracil) for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma
- Additional Method of Administration Approved for Cinvanti in Chemotherapy-Induced Nausea and Vomiting
- FDA Grants Approval to New Formulation of Herceptin
On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Read More ›
In This Article:
- FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
- FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma
In This Article:
- FDA Resumes Operations After Government Shutdown Ends
- FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
- FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. Read More ›
This week Sellas Life Sciences Group announced data from a study of NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab) in patients with HER2 1+/2+ breast cancer. Read More ›
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 (Actemra; Genentech), a humanized interleukin-6 receptor antagonist, for the treatment of patients aged ≥2 years with CAR T-cell–induced severe or life-threatening cytokine release syndrome (CRS). Read More ›
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. Read More ›