FDA Approvals, News & Updates

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.

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