Dec. 31, 2019
The new year will end in a zero, making this a perfect opportunity to look back at the past 10 years of drug approvals.
Complaints abound that the drug industry lacks innovation. A quick perusal of the new drugs approved over the last decade shows that isn’t so. We dug through every drug that passed muster with the Food and Drug Administration starting in 2010 and identified ten — along with a dozen honorable mentions — that have had the biggest impact on the companies that sell them, on medicine, and on society as a whole.
About the Authors
At the risk of defying what has become common wisdom, laying a lot of blame for the opioid crisis at the feet of FDA is misguided. They approve drugs, including their indication. They review promotional content to ensure it stays in label. They did their job – the indication was narrow and I have to believe the promotional content reflected the label. Blame for the behavior of the Insys marketing and sales team and company management lies with the company and the individuals. Some of that behavior would have been discovered in due time, but FDA needs secondary sources and hard evidence to act on this sort of behavior. I’m not saying FDA is blameless, but calling them out here feels inappropriate. (And no, I do not nor have I ever worked for FDA.)
Lynparza is not for lung cancer.
Indications and Usage for Lynparza
1.1 First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer
Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1)].
Maintenance Treatment of Recurrent Ovarian Cancer
Lynparza is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
Advanced gBRCA-mutated Ovarian Cancer After 3 or More Lines of Chemotherapy
Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAmadvanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. [see Dosage and Administration (2.1)].
1.4 Germline BRCA-mutated HER2-negative Metastatic Breast Cancer
Lynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1)].
https://www.drugs.com/pro/lynparza.html
Vascepa??? … your ability to ignore the biggest development in heart disease is truly impressive