FDA Updates

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).

On April 28, 2011, the US Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga, Johnson & Johnson) for the treatment of metastatic castration-resistant prostate cancer (CRPC) for patients who have failed docetaxel therapy. Prostate cancer is a leading cause of cancer mortality and morbidity in the United States.^1,2 Each year approximately 215,000 men are diagnosed and 32,000 men die of the disease. Read More ›

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.

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 Ad ministration (FDA) held a public meeting in February to assess whether stricter criteria are needed when considering oncology drugs for accelerated approval. Measures enacted in 1992 allow the FDA to grant accelerated approval for drugs targeted at unmet needs in cancer based solely on data from single-arm studies and relying on end points other than the standard metric of overall survival. Read More ›

APP Pharmaceuticals has issued a voluntary recall of 5 lots of irinotecan hydrochloride injection (Camptosar) as a precautionary measure. No adverse events related to the recalled products have been reported. The following lots have been recalled:

Bevacizumab (Avastin, Genentech) has been a popular first-line treatment for metastatic breast cancer since 2008, when the US Food and Drug Administration (FDA) granted special, fast-track approval for use in combination with paclitaxel. The accelerated approval was based on positive early findings from the E2100 trial, which showed that the addition of bevacizumab added 5.5 months of progression-free survival (PFS) over paclitaxel alone. Read More ›