Lenvatinib mesylate

With the pivotal bioequivalence (BE) study successfully completed, Adalvo is set for DCP submission of Lenvatinib Oral Liquid (OL) in April 2026. Approximately 60% of patients diagnosed with thyroid cancer struggle to swallow capsules because of tumour location. Lenvatinib OL addresses this significant unmet need: as a convenient, ready-to-use liquid, it improves adherence and simplifies administration. A single strength covers all therapeutic doses, removing the complexity of multi-capsule configurations. Based on the reference brand Lenvima, Lenvatinib OL is indicated for the treatment of Differentiated Thyroid Carcinoma (DTC), Hepatocellular Carcinoma (HCC), and Endometrial Carcinoma (EC). Developed as a 505(b)(2) application for the U.S. and a hybrid application in the EU, Lenvatinib OL marks a significant milestone in a technically demanding program. The complexity in manufacturing this highly potent cytotoxic liquid has been successfully addressed by Adalvo, and is protected by our own patent application. It allows Adalvo to offer partners a Day-1 opportunity with a unique and highly differentiated oncology asset. According to IQVIA, Lenvima global sales exceeded $2.2 billion by Q2 2025, representing a two-year CAGR of 14.66%. To discuss licensing opportunities, or to explore our full oncology portfolio, contact a member of the team today.

A preliminary interim analysis from a late-stage study of Merck & Co.'s Welireg (belzutifan) in earlier-stage clear cell renal cell carcinoma (RCC) showed that the oral HIF-2α inhibitor significantly boosting disease-free survival (DFS) when combined with the PD-1 inhibitor Keytruda (pembrolizumab) as adjuvant therapy following nephrectomy. The latest readout — building on findings highlighted last October — prompted a priority review by the FDA, with a target action date of June 19. The LITESPARK-022 trial randomised 1841 patients to receive either Welireg plus Keytruda for approximately one year, or Keytruda plus placebo, with the primary endpoint being DFS. Results presented Saturday at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) showed that Welireg plus Keytruda lowered the risk of disease recurrence or death by 28% compared with Keytruda plus placebo at a median follow-up of 28.4 months. While the estimated 24-month DFS rate was 80.7% for the combination arm versus 73.7% for the control arm, median DFS was not reached in either group. The trial's key secondary endpoint of overall survival (OS) continues to be evaluated. "These findings represent the first positive Phase III data for Welireg in earlier stages of disease, as well as the first positive Phase III results for a HIF‑2α inhibitor and immunotherapy combination," said M Catherine Pietanza, VP of global clinical development at Merck Research Laboratories. Welireg is approved in multiple regions for advanced RCC following prior PD-(L)1 and VEGF-targeted therapies, whereas Keytruda is authorised across the US, EU, Canada and Japan in the adjuvant RCC setting. Merck's pivotal LITESPARK programme in RCC also includes LITESPARK-011, wherein Welireg plus Eisai's oral tyrosine kinase inhibitor Lenvima (lenvatinib) improved progression-free survival (PFS) versus Exelixis' Cabometyx (cabozantinib) in the post-immunotherapy setting. Having been top-lined as positive last year, data presented at ASCO GU showed that with a median follow-up of 29 months, Welireg in combination with Lenvima reduced the risk of disease progression or death by 30% compared to Cabometyx, with median PFS in the two groups of 14.8 months and 10.7 months, respectively. The trial also demonstrated a trend toward improvement in survival, with median OS of 34.9 months for Welireg plus Lenvima, versus 27.6 months for Cabometyx. Based on the findings, submissions to expand the use of Welireg in combination with Lenvima have been accepted by the FDA, with a target review data of October 4. Meanwhile, the ongoing LITESPARK-012 trial, due to read out later this year, is evaluating the addition of Welireg to Keytruda plus Lenvima in first-line advanced RCC. For more, see – Spotlight On: Evolving treatment trends in RCC and Spotlight On: Rising use of adjuvant Keytruda among major RCC treatment trends. The content above comes from the network. if any infringement, please contact us to modify.