FDA Updates: May 12, 2010

Tarceva (erlotinib) was approved by the FDA for maintenance treatment in patients with locally advanced or metastatic non—small cell lung cancer (NSCLC) whose disease has not progressed after 4 cycles of first-line chemotherapy with a platinumbased regimen. The decision contradicted an ODAC panel’s 12 to 1 recommendation against approval in December 2009.

Keryx Biopharmaceuticals received Fast Track designation for perifosine, a potential first-in-class oral anticancer agent that inhibits Akt activation and affects other signaling pathways, as a treatment for refractory advanced colorectal cancer. Keryx will soon initiate a phase III trial investigating perifosine combined with capecitabine under a special FDA-approved protocol.

In a response to NEXM’s Investigational New Drug application for PrevOnco, the FDA gave the company clearance to initiate a phase II trial of the drug in combination with doxorubicin. PrevOnco has orphan drug status and is being investigated in advanced, unresectable hepatocellular carcinoma. The letter gives NEXM permission to move directly into a phase III trial pending positive results from the phase II study.

The FDA announced that Lundbeck, the company that manufactures Mustargen (mechlorethamine HCl), a nitrogen mustard used in chemotherapy regimens for hematologic malignancies, expects a shortage in the drug’s supply that will last until 2011. Priority for the remaining supply is being given to patients already receiving the drug. More information is available at http://www.ashp.org/shortages.

The FDA rejected a New Drug Application from Cell Therapeutics for Pixuvri (pixantrone), a novel agent developed to treat non-Hodgkin lymphoma, voting 9 to 0 against the application. The panel echoed criticisms from an earlier FDA panel about execution of the supporting trial and suggested another trial to verify the drug’s safety and effectiveness.