FDA Updates in Oncology (May/June)

Cysview™ (hexaminolevulinate HCL), an optical imaging agent, has been approved by the FDA for cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients with known or suspected bladder cancer. Approval is based on data from the pivotal 305 trial, which demonstrated a significantly improved rate of bladder cancer detection using Cysview cystoscopy compared with standard white light cystoscopy alone in patients with non-muscle-invasive papillary bladder cancer. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic system.

Roche Diagnostics has received premarket approval from the FDA for its Elecsys Antibody to Hepatitis C Virus (anti-HCV) assay. This 18-minute in-vitro diagnostic test, which provides a qualitative assessment of total antibodies to hepatitis C virus in human serum or plasma, is designed for use with Roche's electrochemiluminescence technology. When assay results are used in conjunction with other laboratory results and clinical information, they may aid in the presumptive diagnosis of HCV infection in individuals with signs and symptoms of hepatitis or at risk for HCV infection. HCV infection is associated with the development of hepatocellular carcinoma.

The FDA has granted priority review status to Eisai’s new drug application for eribulin mesylate, also known as E7389, as a treatment for locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane. Eribulin is a non-taxane, microtubule dynamics inhibitor, which is derived from Halichondria okadai, a marine sponge. Eisai has also submitted applications for the approval of eribulin to regulatory agencies in Japan and the European Union.

The FDA’s Oncologic Drugs Advisory Committee will meet on July 20 to review two supplemental Biologics License Applications (sBLAs) for Avastin: (1) as a first-line treatment for patients with metastatic HER2-negative breast cancer in combination with docetaxel or another chemotherapeutic agent; and (2) in combination with paclitaxel in some breast cancer patients who have not received chemotherapy. The first sBLA is based on data from AVADO and the second on data from RIBBON 1; both are phase III studies that met their primary endpoints and demonstrated increased progression-free survival when Avastin was added to common chemotherapy regimens versus chemotherapy administered alone.

The FDA has granted orphan drug designation to pralatrexate (Folotyn) for the treatment of advanced or metastatic transitional cell carcinoma (TCC) of the urinary bladder. Allos Therapeutics is currently investigating pralatrexate in a phase II trial in this patient population. TCC accounts for over 97% of bladder cancers.