Eisai launches Lenvima in US
pharmafile | March 2, 2015 | News story | Sales and Marketing | FDA, Japan, Lenvima, US, dtc, thyroid
Japanese firm Eisai has launched its new thyroid cancer offering Lenvima in the US, making it the first country in the world to see the treatment.
Lenvima (lenvatinib mesylate) is a molecular targeted agent that blocks the activities of several molecules that are involved in the development of tumours, and in the growth of thyroid cancer.
In a Phase III trial people with thyroid cancer who were treated with Lenvima showed a statistically significant improvement in progress-free survival compared to people who took a placebo, and a favourable response rate.
In February the FDA approved Lenvima in the US to treat the most common type of thyroid cancer – differentiated thyroid cancer (DTC) – for patients whose disease has progressed despite receiving radioactive iodine therapy.
Lenvima was evaluated under the FDA’s priority review programme, and the drug also received orphan product designation because it is intended to treat a rare disease. The firm is now trialling the drug for other tumour types, and Lenvima is undergoing regulatory review worldwide and the EU (where it has also been granted accelerated assessment).
Eisai is also running a global Phase III trial of the drug in hepatocellular carcinoma, as well as Phase II studies of Lenvima in several other cancers – such as renal cell carcinoma and non-small cell lung cancer.
In a statement the company says: “Eisai is committed to exploring the potential clinical benefits of Lenvima in order to further contribute to address the diverse needs of, as well as increase the benefits provided to, patients with cancer, and their families.”
Although treatment is possible for most types of thyroid cancer – including surgery, radiotherapy, or thyroid hormone replacement treatment, there are fewer treatment options available once thyroid cancer has progressed. In the US some 52,000 people were diagnosed with thyroid cancer in 2012.
Lilian Anekwe
Related Content
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
