Drugs

Breakthrough Status for Gynecologic Cancer Therapy

FDA has granted Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan (R-DXd), an investigational drug for treating patients with certain forms of platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. The designation covers patients whose tumors express CDH6 and who have previously been treated with the drug bevacizumab, a Merck release says.

The companies describe raludotatug deruxtecan as a potential first-in-class antibody-drug conjugate designed to target CDH6, a protein overexpressed in a majority of ovarian cancers. The FDA decision was supported by early results from a Phase 1 trial as well as the ongoing REJOICE-Ovarian01 phase 2/3 study, they say.

Ovarian cancer remains one of the deadliest gynecologic malignancies, with more than 324,000 women diagnosed globally each year, according to Merck. For patients whose disease becomes resistant to platinum-based chemotherapy, prognosis is especially poor, and treatment options are limited, it says, adding that about two-thirds of ovarian cancer tumors express CDH6.

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