Drugs

Keytruda Approved for FIGO Cervical Cancer

FDA has approved Merck’s Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervical cancer. Approval is based on data from the KEYNOTE-A18 (NCT04221945) trial that enrolled 1,060 patients with cervical cancer who had not previously received definitive surgery, radiation, or systemic therapy. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) in the overall population, an FDA release says.

“In an exploratory subgroup analysis in the 596 patients with FIGO 2014 Stage III-IVA ‑ disease, the PFS hazard ratio (HR) estimate was 0.59 (95% CI: 0.43, 0.82), and 21% of patients in the pembrolizumab arm experienced a PFS event compared to 31% of patients in the placebo arm,” it says. “In contrast, in an exploratory subgroup analysis in the 462 patients with FIGO 2014 Stage IB2-IIB disease, the PFS HR estimate was 0.91 (95% CI: 0.63, 1.31), indicating that the PFS improvement in the overall population was primarily attributed to patients with FIGO 2014 Stage III-IVA disease.”

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