FDA Approval for Talc
- Approved for malignant pleural effusions
Full prescribing information is available, including clinical trial information, safety,dosing, drug-drug interactions and contraindications.
On December 15, 2003, the U.S. Food and Drug Administration approved talc (Sterile Talc Powder™, a trademark of Bryan Corporation), administered intrapleurally (within the pleural cavity) via chest tube, as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.
Malignant pleural effusion results from an accumulation of fluid in the pleural space, the area between the layer lining the chest cavity (parietal pleura) and the membrane covering the lungs (visceral pleura). It is a common complication of malignant disease, particularly in patients with advanced cancer.
The data demonstrating safety and efficacy are from the published medical literature. There were five randomized studies that were designed to evaluate the risk of recurrence of malignant pleural effusions in patients with a variety of solid tumors. For each study, talc slurry was compared with a concurrent control, using a prospectively defined objective measure of "success." For the 89 evaluable patients studied in the five randomized controlled trials, there was an 89 percent success rate (range 79-100 percent). Thirteen additional single-arm trials and retrospective series from the literature are also supportive of efficacy with variously defined “success” rates ranging from 75-100 percent.
Adverse events (AEs) most frequently reported in the literature in association with intrapleurally administered talc slurry are fever and pain. Acute pneumonitis and Acute Respiratory Distress Syndrome (ARDS) have been reported in association with intrapleural talc administration.
Talc should be administered after adequate drainage of the effusion. The success of pleurodesis appears to be related to the completeness of drainage of the pleural fluid, as well as the full re-expansion of the lung. The recommended dose is 5 grams, dissolved in 50-100 milliliters of sodium chloride solution. Although the optimal dose for effective pleurodesis is unknown, 5 grams was the dose most frequently reported in the published literature.
The only other licensed formulation of talc (Sclerosol Intrapleural Aerosol™, also made by Bryan Corporation) is packaged with a chlorofluorocarbon (CFC) propellant for direct insufflation into the open pleural surface intraoperatively or during thoracoscopy.
This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.
The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Understanding the Approval Process for New Cancer Treatments.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.