Anita Shaffer
Articles
FDA to Reassess Accelerated Immunotherapy Approvals
March 12, 2021
Article
Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.
August Adverse Events Report: FDA Labeling Changes
August 10, 2017
Article
An update on the labeling changes from the FDA.
June Adverse Events Report: FDA Labeling Changes
June 22, 2017
Article
FDA labeling changes reflecting adverse events.
Adding Pertuzumab to Trastuzumab Shows Benefits in Early HER2-Positive Breast Cancer
June 14, 2017
Article
Adjuvant pertuzumab may help some early breast cancer patients.
Newly Diagnosed Patients Better Manage Stress With Web-Based STREAM Therapy
June 07, 2017
Article
Patients new diagnosed with cancer were able to improve quality of life and distress by through a web-based stress management program.
Abiraterone Lowers Risk of Death from Prostate Cancer in Two Clinical Trials
June 06, 2017
Article
According to findings presented at the 2017 ASCO Annual Meeting, earlier intervention with abiraterone acetate (Zytiga) lowered the risk of death by 40% for men with high-risk advanced or metastatic prostate cancer.
Shorter Adjuvant Chemo in Colon Cancer Is Effective, Reduces Neuropathy Risk
June 05, 2017
Article
According to findings presented at the 2017 ASCO Annual Meeting, patients with low-risk advanced colon cancer would benefit from a reduction in chemotherapy post-surgery, without increasing risk of recurrence, to reduce risk of neuropathy.
May Adverse Events Report: FDA Labeling Changes
May 30, 2017
Article
Recent changes to FDA labels regarding adverse events.
April Adverse Events Report: FDA Labeling Changes
April 21, 2017
Article
The adverse events report featuring FDA labeling changes for bendamustine hydrochloride, nilotinib, dinutuximab.
Trial Examines Triplet Regimen in Ovarian Cancer
February 14, 2017
Article
In a current phase II/III clinical trial for patients with advanced, recurrent, platinum-resistant ovarian cancer, the novel agent fasbretablin tromethamine is combined with bevacizumab (Avastin) and either paclitaxel or pegylated liposomal doxorubicin.