Cath Lab Digest

Product News

New Combination Oral Contraceptive
The US Food and Drug Administration (FDA) has approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at 4 times throughout each 28-day treatment cycle. The product is manufactured by Bayer HealthCare Pharmaceuticals.
The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multicenter phase 3 clinical trials in North America and Europe. The trials involved 1867 women and nearly 30,000 28-day treatment cycles. Natazia was found to be effective as a hormonal contraceptive in both studies.

Immunotherapy Cleared for Prostate Cancer
Sipuleucel-T (Provenge), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease, has been approved by the FDA. The treatment is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. Sipuleucel-T is manufactured by Seattle-based Dendreon Corp.

Sipuleucel-T is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of sipuleucel-T is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. sipuleucel-T is administered intravenously in a 3-dose schedule given at about 2-week intervals.

The effectiveness of sipuleucel-T was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving sipuleucel-T treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Device for Asthma
The first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults has been approved by the FDA. The Alair Bronchial Thermoplasty System is intended for patients ages ≥18 years whose severe and persistent asthma is not well controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system. The agency is requiring a 5-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx Inc, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.