Drugs

Merck Touts New Keytruda Endometrial Cancer Data

Merck says it will meet with regulatory authorities about an expanded indication after reporting results from the Phase 3 NRG‑GY018 trial of its anti-PD-1 therapy Keytruda being evaluated in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with Stage 3-4 or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR).

Data from its trial, according to the company, showed that the Keytruda regimen “demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients, regardless of mismatch repair status.” In the pMMR cohort of 591 evaluable patients, after a median follow-up of 7.9 months, Merck says the Keytruda regimen reduced the risk of disease progression or death by 46% compared to chemotherapy alone. In the dMMR cohort of 225 evaluable patients, the drug regimen reduced the risk of disease progression or death by 70%.

Keytruda is currently approved for use in combination with Eisai’s Lenvima (lenvatinib) for treating patients with advanced endometrial carcinoma that is pMMR, as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy. It is also approved as a single agent for treating patients with advanced endometrial carcinoma that is microsatellite instable or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any 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

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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