Lung cancer patients who fail to respond to two or more types of chemotherapy may now benefit from Iressa — a last-resort medication approved by the FDA in May.

Taken in tablet form once per day, Iressa (gefitinib) acts as a single-agent treatment for patients with advanced non-small-cell lung cancer (NSCLC), the most common form of lung cancer in the United States, according to the FDA. The FDA based its approval on the results of a study that showed Iressa—manufactured by AstraZeneca Pharmaceuticals LP, Wilmington, Del—shrinks tumors in about 10% of patients with lung cancer who have already received platinum-based and docetaxel chemotherapy. The results showed no benefit from adding the drug to standard, platinum-based chemotherapy. Therefore, the FDA does not indicate Iressa for use in that setting.

Researchers do not fully understand how Iressa works. However, they do know that it blocks several tyrosine kinases—enzymes that mediate growth stimulatory signals in cancer cells—including the one associated with the epidermal growth factor receptor (EGFR).

Ronald Natale, MD, principal investigator on the Iressa clinical trial at Cedars-Sinai Medical Center, Los Angeles, was surprised Iressa did not work in a higher percentage of lung cancer patients. He attributed that in part to the complexity of the EGFR signal transduction pathway.

“The signal to the nucleus of the cancer cell can go through multiple signal transduction pathways, and I think Iressa—because it’s such a focused, targeted agent—only affects some of those downstream pathways,” says Natale, who is also the acting medical director at Cedars-Sinai Comprehensive Cancer Center. “We think that combining Iressa with other molecules that target other locations within the signal transduction pathways has the potential to improve results significantly.”

Iressa was reviewed and approved under an FDA program intended to allow patients suffering from serious or life-threatening diseases earlier access to promising new drugs. As required by the program’s regulations, Iressa’s developer will perform additional studies to verify the drug’s clinical benefit.

“FDA believes it is crucial for cancer patients to have many safe and effective treatment options available to them in their battle against this disease” says FDA Commissioner Mark B. McClellan, MD, PhD. “With the approval of Iressa, thousands of patients with lung cancer will now have access to an additional treatment after others haven’t worked to stop the progression of their disease.”

Datex-Ohmeda, Aerogen Team Up
Due to a recent supply agreement, Mountain View, Calif-based Aerogen Inc will provide Datex-Ohmeda, Louisville, Colo, a division of Instrumentarium, with a modified Aeroneb Professional Nebulizer System for integration into future critical care products. The nebulizer system incorporates Aerogen’s OnQ™ aerosol generator. According to the companies, the arrangement will improve the efficiency of drug delivery and critical care equipment.

Nellcor Celebrates 1 Year With Oximax

Marking the most successful product launch in Nellcor’s 20-year history, OxiMax pulse oximetry system sales surpassed 15,000 units just a year after its market debut. Through the addition of a digital memory chip in the sensor, the OxiMax pulse oximetry system integrates intelligence into both the sensor and the monitor, according to Pleasanton, Calif-based Nellcor, a division of Tyco Healthcare. The system comprises the Nellcor N-595 pulse oximeter and the line of OxiMax sensors, including the MAX-FAST™ adhesive forehead sensor, which detects changes in SpO2. Featuring advanced digital signal processing algorithms, the system is available to Nellcor’s original equipment manufacturer partners through a new series of pulse oximetry modules, including the MP-506 module.

ResMed Earns Two Top 100 Companies Rankings

Two major business publications recently applauded the growth success of ResMed Inc, San Diego. BusinessWeek rated the respiratory medical device manufacturer number 32 in its 100 Hot Growth Companies list for 2003, and Investor’s Business Daily ranked the company number 89 in its latest Top 100 Companies in America. “We are once again gratified by this recognition of ResMed’s continuing growth, which reflects a team commitment by all ResMed employees,” says Peter C. Farrell, PhD, CEO of ResMed. The BusinessWeek listing is based on “3-year results in sales growth, earnings growth, and return on invested capital.” The Investor’s Business Daily list is based on a “company’s recent earnings growth record; IBD’s ‘composite rating,’ which includes key measures, such as return on equity, sales growth, and profit margins; and relative price performance in the last 12 months.”

CareFore Receives Exporting Award

On June 5, Kansas Governor Kathleen Sebelius recognized CareFore Medical Inc, Olathe, Kan, as one of four finalists for the 2003 Kansas Governor’s Exporter of the Year award. The award recognizes exceptional performance in developing export markets for the state of Kansas. CareFore develops, manufactures, and distributes respiratory accessories to the home health care and hospital market worldwide.