FDA Approvals, News & Updates
By Phoebe Starr
On January 14, 2019, the FDA approved cabozantinib (Cabometyx; Exelixis) an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib (Nexavar). Read More ›
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men. Read More ›
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men. Read More ›
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men. Read More ›
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services. Read More ›
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 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. Read More ›
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 ›