The FDA has granted accelerated approval to tucatinib (Tukysa®, Seagen, Inc.) with trastuzumab for rat sarcoma (RAS) wild-type human epidermal growth factor receptor 2 (HER2)–positive unresectable or metastatic colorectal cancer (CRC) that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. "Patients with chemotherapy-refractory HER2-positive metastatic colorectal cancer receive limited clinical benefit with currently available therapies," said John Stric...

Oncology Data Advisor™ · Do Accelerated Approvals Really Benefit Patients? With Ravi Parikh, MD, MPP Recently, Ravi Parikh, MD, MPP, an Assistant Professor of Medical Ethics and Health Policy and Medicine at the University of Pennsylvania, Perelman School of Medicine, released a research letter titled, "Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval." In this interview with OncData, he further discusses his resea...

Due to lackluster recruiting techniques, a suboptimal number of patients are selected to participate in clinical trials. In addition, the researchers often have limited ability to observe and coach patients during clinical trials. These factors contribute to high clinical trial failure rates, which have a negative impact on the drug development cycle, not to mention 10 to 15 years and hundreds of millions of dollars wasted. However, scientists have proposed a potential solution to this problem: ...