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FDA Approvals

The US Food and Drug Administration (FDA) has approved Inform Dual ISH (Ventana Medical Systems), a genetic test that allows for measurement of the number of copies of the HER2 gene in tumor tissue. This method of identification of women with breast cancer who are HER2+ pinpoints who is, and who is not, a candidate for Herceptin (trastuzumab).


The US Food and Drug Administration (FDA) has approved a short-acting formulation of oxycodone (Oxecta, Pfizer) that uses “Aversion” technology to stop potential abusers from crushing, chewing, snorting, or injecting the drug. Oral abuse remains possible. In addition, Pfizer acknowledged that the potential to abuse the drug through all routes is feasible.


The drug is indicated for acute and chronic moderate-to-severe pain.

The US Food and Drug Administration (FDA) has approved a 45 mg for 6-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot, Abbott) for palliative treatment of advanced prostate cancer. This dosing option adds to the existing formulations, which are injected every 1 month, 3 months, and 4 months.


This past Friday, the US Food and Drug Administration (FDA) approved 2 drugs that could help our patients: fentanyl nasal spray (Lazanda, Archimedes Pharma) and rivaroxaban (Xarelto, Janssen Pharmaceuticals).


As many as 1 in 5 cancer patients may experience obstacles in their care, according to a new study published in the Journal of Clinical Oncology. These obstacles include communication issues between patients and their healthcare providers, along with traditional medical errors.

The US Food and Drug Administration (FDA) approved many new cancer drugs and several new indications for previously approved drugs in 2013, as well as the first 2 drugs designated as “breakthrough therapy.”
The following briefs provide updates on new FDA approvals and indications to help hematology and oncology pharmacists keep up with new information regarding drugs that are coming to market for the management of patients with cancer.
First Anti–PD-1 Immunotherapy, Pembrolizumab, Receives Accelerated FDA Approval for Advanced Melanoma;
Ibrutinib Received Expanded Indication for Patients with CLL and 17p Deletion;
FDA Approved Idelalisib for Three Types of Hematologic Cancers;
Belinostat Approved for Peripheral T-Cell Lymphoma, an Aggressive Form of NHL;
Lymphoseek Injection Received Expanded Indication for Head and Neck Cancer SLN Biopsy
On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
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