Drugs

Merck Reports Promising Keytruda-Welireg Combo Data

Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence or death in certain patients with earlier-stage renal cell carcinoma (RCC), marking the first positive Phase 3 study of the HIF-2α inhibitor in early-stage disease. Results from the pivotal Phase 3 LITESPARK-022 trial, presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium, showed that the combination reduced the risk of recurrence or death by 28% compared with Keytruda alone, it says.

Merck says the study enrolled patients with clear cell RCC at increased risk of recurrence following nephrectomy. After a median follow-up of 28.4 months, median disease-free survival had not yet been reached in either arm. The estimated 24-month DFS rate was 80.7% in the combination arm versus 73.7% with Keytruda plus placebo. It adds that the trial will continue to assess overall survival, a key secondary endpoint.

Clinical investigators say the findings could shift the adjuvant treatment paradigm. Roughly 40% of patients with renal cell cancer experience recurrence after initial therapy, underscoring the need for more effective post-surgical options.

Based on data from the LITESPARK-022 trial, Merck says FDA has accepted for priority review supplemental applications seeking approval of Welireg in combination with Keytruda Or Keytruda Qlex for the adjuvant treatment of adult patients with RCC with a clear cell component with increased risk of recurrence following nephrectomy. The agency has set a user fee review action target date of 6/19.

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