Drugs

Progression-Free Survival Improves in DUO-E Trial: AZ

AstraZeneca says the Phase 3 DUO-E trial showed statistically significant and clinically meaningful improvement in progression-free survival of advanced endometrial cancer when its Imfinzi (durvalumab) was used in combination with platinum-based chemotherapy and followed by Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy. A company announcement says there was a greater benefit observed with the combination of Imfinzi and Lynparza as maintenance therapy.

Imfinzi is described as a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins. It is the only approved immunotherapy for unresectable Stage 3 non-small-cell lung cancer in patients whose disease has not progressed after chemotherapy. It also is approved in the U.S. to treat extensive-stage small-cell lung cancer.

Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response in cells/tumors harboring a deficiency in homologous recombination-related genes. It is approved in several countries for use with several tumor types.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome