Drugs

Gilead/Merck Stop Trodelvy/Keytruda Study

Gilead and Merck say they are discontinuing the KEYNOTE-D46/EVOKE-03 study of Gilead’s Trodelvy (sacituzumab govitecan-hzly) and Merck’s Keytruda (pembrolizumab) as a treatment for certain patients with previously untreated metastatic non-small cell lung cancer whose tumors expressed PD-L1. A statement says the decision was based on a recommendation from the external data monitoring committee following a review of the data from the pre-specified final analysis of progression-free survival and interim analysis of overall survival.

The statement says a numerical improvement in progression-free survival was observed, but did not reach statistical significance. It says the probability of achieving statistically significant overall survival is unlikely at the planned final analysis.

Gilead says Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate that is being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. It is currently indicated to treat adults with:

unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease; and
unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

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