FDA Updates in Oncology

Tarceva (erlotinib) becomes the latest drug 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 platinum-based regimen.

Tarceva (erlotinib) becomes the latest drug 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 platinum-based regimen. The decision contradicted an ODAC panel's 12 to 1 recommendation against approval in December 2009. Approval was based on results from the SATURN study, involving 889 patients with non-progressing NSCLC after first-line chemotherapy; 70% had tumors positive for EGFR. The study showed a modest 1.2-week improvement in the primary endpoint of progression-free survival and a median 1-month improvement in overall survival (12 mo vs 11 mo).

The FDA announced that Lundbeck, the company that manufacturers 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, and the FDA urges physicians to consider alternative therapies. Lundbeck was transitioning production to a new manufacturer, but the arrangement fell through and the company is attempting to secure a new supplier to resume production. More information is available at the American Society of Health-System Pharmacists' Website.

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. Overexpression of Akt is associated with drug resistance and poor prognosis in various cancer types. This quarter, Keryx will initiate a phase III trial investigating perifosine combined with capecitabine under a special FDA-approved protocol. Results are expected in 2011.

The FDA scheduled a meeting with the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees to discuss CytRx's New Drug Application for Acurox (oxycodone HCl and niacin). Niacin, a nasal irritant, was added to the drug's formulation to discourage would-be drug abusers from inhaling the pain reliever. The FDA has questioned whether the deterrent will be effective, noting that drug users could pretreat their nose with nasal-numbing chemicals or crush the tablets and snort them without being aware initially of their irritating effects.

The FDA rejected a New Drug Application from Cell Therapeutics for Pixantrone, a novel agent developed to treat non-Hodgkin lymphoma, voting 9 to 0 against the application. The panel echoed criticisms from an FDA panel convened earlier this year about how the supporting trial was conducted and suggested another trial to verify Pixantrone's safety and effectiveness. Cell Therapeutics said it will ask to meet with the FDA to design a follow-on study and expand access to the trial.

On the supportive care side, the FDA has approved Oravig by Strativa Pharmaceuticals, the first and only localized oral miconazole therapy to treat thrush. Thrush commonly occurs in immunocompromised patients, such as individuals with cancer. The 50-mg tablet is administered once daily and the medication adheres to the gum at the site of the infection.

The FDA is studying whether Stalevo (carbidopa/levodopa/entacapone), a drug used to treat Parkinson’s disease, can increase the risk of prostate cancer. The assessment results from a 4-years study that revealed that men taking Stalevo had a higher incidence of prostate cancer compared with those taking Sinemet (carbidopa/levodopa), with 3.7% of men taking Stalevo receiving a prostate cancer diagnosis compared with 0.9% of those taking Sinemet. The FDA’s investigations are ongoing and no no new conclusions or recommendations have been made regarding use of either drug.

The FDA is considering reclassifying tanning beds and tanning lamps as Class II or Class III medical devices, which would allow the FDA to regulate how much radiation is emitted by these devices. Currently, tanning beds are classified as Class I devices, meaning they are considered to cause little if any harm, yet studies have revealed that using a tanning bed before the age of 35 increases the risk of melanoma by 75%.

The FDA has launched a Web page to educate the public about the processes and decision-making rationales for the development of regulations concerning radiation-emitting medical devices. The page, which is available at the FDA Website, is part of the FDA’s Transparency Initiative. On the page, visitors will find information about regulatory decisions and the rationales for those decisions, descriptions of regulatory processes, and data to support the Center for Devices and Radiological Health’s (CDRH) actions and public health activities.

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