FDA Approvals, News & Updates

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).

 

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:

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.

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.

Page 14 of 14
Results 131 - 136 of 136