Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their drugs. To this end, they have conducted clinical trials testing each as a first-line treatment (i.e., in previously untreated patients), comparing them to standard chemotherapy. Continue reading…
“The FDA today approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer.
“The agent is indicated for PET imaging in men who have suspected prostate cancer recurrence based on elevated PSA levels following treatment.
“The FDA based its decision on results of two studies that evaluated the safety and efficacy of Axumin (Blue Earth Diagnostics). One study compared 105 Axumin scans to histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in men suspected of having prostate cancer recurrence. In the second study, researchers evaluated 96 Axumin scans with C11 choline scans in patients with a median PSA of 1.44 ng/mL.”
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“The FDA should wait for results of an ongoing phase III clinical trial before deciding whether to approve the EGFR inhibitor rociletinib for non-small cell lung cancer (NSCLC), advisers recommended today.
“The Oncologic Drugs Advisory Committee (ODAC) voted 12-1 in favor of the delay, although several committee members acknowledged that the drug demonstrated activity in two phase II trials submitted in support of the application for accelerated approval. Others, however, expressed a desire to see more compelling efficacy data from the larger, phase III trial, and some expressed uncertainty about about how to interpret the drug’s safety, specifically a 33% incidence of QT-prolongation in the single-arm phase II trials.
“Additionally, FDA staff review of the trial data ‘revealed high variability of systemic exposure to rociletinib and its major metabolites. Rociletinib demonstrated nonlinear pharmacokinetics, as systemic exposures did not increase when the dose increased from 500 mg to 1000 mg.’ ”
“A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug’s developer, Lexicon Pharmaceuticals.
“The application was based on data from two phase III trials, both of which demonstrated significant reductions in the frequency of daily bowel movements with telotristat etiprate versus placebo. In the first study, TELESTAR, telotristat etiprate reduced daily bowel movements by up to 35%. In the second study, TELECAST, there was also a significant reduction in bowel movements (P ≤.004), although the exact data were not yet released.
“The FDA will review the NDA within 60 days of submission, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. Lexicon requested a priority review for the NDA, which would provide a 6-month deadline if the designation is granted.”
Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…