Merck & Co Inc: FDA accepts review of two supplemental NDAs for Welireg plus Lenvima

Merck & Co Inc: FDA accepts review of two supplemental NDAs for Welireg plus Lenvima

Merck & Co Inc: FDA Accepts Review of Two Supplemental NDAs for Welireg Plus Lenvima Combination

The U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) submitted by Merck & Co Inc (NYSE: MRK) for the combination of Welireg (everolimus) and Lenvima (lenvatinib) in the treatment of advanced endometrial cancer. The applications seek approval for the regimen as a first-line therapy for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors who are not candidates for curative surgery or radiation [FDA acceptance indicates the agency has determined the submissions are sufficiently complete to proceed with review. A final decision is expected by August 12, 2026, barring any delays or additional requests for information. If approved, the combination therapy would expand Merck's oncology portfolio and potentially generate incremental revenue, given the growing prevalence of endometrial cancer and the current unmet needs in MSI-H/dMMR subsets [According to analysts, regulatory outcomes for supplemental applications often hinge on robust clinical trial data demonstrating improved patient outcomes. Merck has emphasized its commitment to advancing targeted therapies in collaboration with partners like Eisai, though the company has not provided specific financial projections for this indication. Investors are advised to monitor FDA communications and upcoming clinical data disclosures for further clarity on the application's progress and potential market impact.