Drugs

Keytruda/Chemo Approved for Endometrial Cancer

FDA has approved Merck’s Keytruda (pembrolizumab) for use with carboplatin and paclitaxel, followed by single-agent pembrolizumab in adult patients with primary advanced or recurrent endometrial carcinoma.

Approval was based on data from the KEYNOTE-868/NRG-GY018 (NCT03914612) trial that enrolled 810 patients with advanced or recurrent endometrial carcinoma, according to an agency release. It included two separate cohorts based on mismatch repair (MMR) status — 222 patients in the mismatch repair deficient (dMMR) cohort, and 588 patients in the mismatch repair (pMMR) proficient cohort.

The trial’s primary efficacy outcome was progression-free survival (PFS), assessed by the investigator according to RECIST 1.1. “In the dMMR cohort, median PFS was not reached (NR) (95% CI: 30.7, NR) in the pembrolizumab and chemotherapy arm and 6.5 months (95% CI: 6.4, 8.7) in the placebo and chemotherapy arm (Hazard ratio [HR] 0.30 [95% CI: 0.19, 0.48]; p-value <0.0001),” the release says. “In the pMMR cohort, median PFS was 11.1 months (95% CI: 8.7, 13.5) in the pembrolizumab and chemotherapy arm and 8.5 months (95% CI: 7.2, 8.8) for those receiving placebo and chemotherapy arm (HR 0.60 [95% CI: 0.46, 0.78; p-value <0.0001).”

FDA says that adverse reactions associated with pembrolizumab and chemotherapy were similar to previously reported events with the exception of higher rash incidents.

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