Drugs

Merck sBLA for Keytruda Use in Cervical Cancer

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly diagnosed patients with high-risk locally advanced cervical cancer. The submission is based on data from the KEYNOTE-A18 trial, in which the combination therapy “demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to concurrent chemoradiotherapy alone,” the company says. “If approved, this would be Merck’s third approved indication in cervical cancer and first in an earlier stage of the disease.” The agency has set a user fee review action date of 1/20/2024.

Merck says the standard of care for patients with locally advanced cervical cancer has not changed in more than years. “If approved, Keytruda will be the first immunotherapy available for patients with newly diagnosed high-risk locally advanced cervical cancer,” it says.

Keytruda currently has two cervical cancer-related approvals — in combination with chemotherapy, with or without bevacizumab, for treating patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1; and as a single agent for treating certain patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

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

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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