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News Notes Final Rule on Safety Informa tion during Clinical Trials The US Food and Drug Administration (FDA) issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The new rule requires that certain safety information that previously had not been required to be reported to the FDA be reported within 15 days of
becoming aware of an occurrence. These reports include: • Findings from clinical or epidemiologic studies that suggest a significant risk to study participants • Serious suspected adverse reactions that occur at a rate higher than expected • Serious adverse events from bioavailability studies and bioequivalence studies.
NCCN Launches Guidelines for Patients The National Comprehensive Cancer Network (NCCN) now offers a series of NCCN Guidelines for Patients, consumer-friendly translations of the NCCN Clinical Practice Guidelines in Oncology. The first two guidelines released cover breast and lung cancers. “While there are a number of good resources available to these women, only
the NCCN Guidelines for Patients provide the level of highly specific, current information that patients want and need. We are very proud to take a leadership role in supporting these guidelines and making them available to breast cancer patients,” said Diana Rowden, Survivorship and Outcomes Vice President at Susan G. Komen for the Cure, which supported the breast cancer guidelines through grant funding. The NCCN Guidelines for Pa tients are available at NCCN.com, which also features enhanced content for patients and caregivers. A link to the NCCN Guidelines for Patients: Breast Cancer will also be available at komen.org.
TRUST Study Confirms Safety and Efficacy of Erlotinib Patients previously believed unlikely to benefit from erlotinib treatment may benefit from this treatment, according to recently released results of the Tarceva Lung Cancer Survival Treatment (TRUST) study (J Thorac Oncol. 2010;10:1616-1622). This global phase 4 open-label study in previously treated patients with advanced non–small-cell lung cancer (NSCLC) confirmed the favorable efficacy and safety profile of erlotinib in a large heterogeneous NSCLC population. In a study of 6580 patients with advanced NSCLC, progression-free survival and overall survival in this study were 3.25 months and 7.9 months, respectively, and the disease control rate. ●
Recent FDA Approval FDA Approves Docetaxel Injection One-Vial Formulation The US Food and Drug Administration (FDA) has approved a new one-vial formulation of docetaxel injection concentrate (Taxotere, sanofi-aventis). This new formulation eliminates the initial dilution step, as well as the second vial containing the diluent. With the one-vial formulation, the pharmaceutical ingredients and the 1hour intravenous infusion administration remain unchanged. Docetaxel is approved for use in treating patients at specific stages of metastatic and adjuvant breast cancer, metastatic androgen-independent prostate cancer, advanced non–small-cell lung cancer, advanced gastric adenocarcinoma, and locally advanced squamous cell carcinoma of the head and neck.
OctOber 2010 I VOL 3, NO 7
THE ONCOLOGY PHARMACIST