The FDA has added a warning to the labeling for testosterone products regarding abuse and dependence. Abuse is a problem particularly for adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at higher doses than those prescribed for androgen deficiency and often in association with other androgenic steroids, affects the heart, brain, liver, mental health, and endocrine system. Serious outcomes included myocardial infarction, heart failure, stroke, depression, hostility, liver injury, and male infertility. Those on high doses of testosterone also experienced withdrawal symptoms when high doses were discontinued. The FDA suggests checking serum testosterone levels if a clinician suspects abuse.
The FDA has approved the first immunotherapy for first-line therapy in non-small cell lung cancer (NSCLC). Pembrolizumab is a checkpoint inhibitor, a class of cancer drugs that overcome cancer cells’ ability to fend off attack by T cells. The drug is approved for treatment of tumors that express high PD-L1 levels as determined by an FDA-approved test. The approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC. The approval was based on the results of two randomized, controlled trials that showed statistically significant improvements in progression-free survival and overall survival for patients randomized to pembrolizumab compared with chemotherapy. Pembrolizumab is marketed by Merck as Keytruda. It is significant that Merck tested pembrolizumab in patients with tumors expressing high PD-L1 levels. The drug’s main competition, Bristol-Myers Squibb’s checkpoint inhibitor nivolumab (Opdivo) was the subject of headlines in August when a highly anticipated trial of the drug in lung cancer failed to show benefit, although the study was conducted with patients presenting with all lung cancers, regardless of PD-1 levels.
The FDA has approved the first new drug for treatment of soft tissue sarcoma in more than 40 years with the accelerated approval of olaratumab, a platelet-derived growth factor receptor alpha-blocking antibody. The drug is approved in combination with doxorubicin to treat adults with certain types of soft tissue sarcomas who cannot be cured with radiation or surgery. Approval was based on a randomized, clinical trial of 133 patients presenting with different subtypes of metastatic sarcoma, which show a 12-month improvement in overall survival with the combination compared to doxorubicin alone. Olaratumab received fast-track designation as well as breakthrough therapy designation and priority review status. It also received orphan drug designation, which gives financial incentives for the development of drugs for rare conditions. Olaratumab is marketed as Lartruvo.
The FDA has approved the first insulin delivery system that monitors blood glucose and provides appropriate basal insulin doses for type 1 diabetics ≥ 14 years of age. Medtronic’s new MiniMed 670G hybrid closed looped system is the first of the so-called “artificial pancreas” devices. Manufacturers tested the MiniMed on 123 patients with type 1 diabetes over a three-month period. No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia (low glucose levels) were reported during the study. The device is not approved for children or those who require < 8 units of insulin per day.
In this section: The FDA adds warning label to testosterone products, approves new treatment for non-small cell lung cancer, greenlights drug for soft tissue sarcoma patients, and gives its blessing to the so-called 'artificial pancreas.'
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.