Lenvima fda approval history?

When was Lenvima first approved by the FDA?

Lenvima, also known as lenvatinib, was first approved by the US Food and Drug Administration (FDA) in 2014 for the treatment of a specific type of thyroid cancer called radioactive iodine-refractory differentiated thyroid cancer [1]. The approval was based on data from a clinical trial that demonstrated the efficacy and safety of Lenvima in treating this condition.

What are the key milestones in Lenvima's FDA approval history?

* In 2013, Lenvima was granted Breakthrough Therapy Designation by the FDA for the treatment of radioactive iodine-refractory differentiated thyroid cancer [2].
* In December 2014, the FDA approved Lenvima for the treatment of radioactive iodine-refractory differentiated thyroid cancer [3].
* In July 2016, the FDA approved Lenvima in combination with everolimus for the treatment of advanced renal cell carcinoma [4].
* In 2017, the FDA expanded the approval of Lenvima to include its use in combination with pembrolizumab for the treatment of patients with advanced renal cell carcinoma who have a clear cell histology and a programmed death-ligand 1 (PD-L1) tumor proportion score ≥ 1% [5].
* In 2020, the FDA granted accelerated approval to Lenvima in combination with pembrolizumab for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib [6].

What are the indications for Lenvima currently approved by the FDA?

Lenvima is currently approved by the FDA for the treatment of several cancer types, including:

* Radioactive iodine-refractory differentiated thyroid cancer
* Advanced renal cell carcinoma
* Hepatocellular carcinoma (HCC)
* Advanced endometrial carcinoma

What are some of the side effects associated with Lenvima?

Like all medications, Lenvima can cause side effects. Common side effects include hypertension, diarrhea, fatigue, decreased appetite, and mucositis [7]. More serious side effects can also occur, including hepatic failure, myocardial infarction, and pulmonary embolism [8].

What is the patent status of Lenvima?

Lenvima is patented by Eisai Co., Ltd., the manufacturer of the medication. The patent for Lenvima is set to expire in 2032, although the company may apply for extensions or new patents to maintain exclusivity [9].

Sources:
[1] FDA. (2014). Lenvatinib (Lenvima) Approved for Differentiated Thyroid Cancer.
[2] FDA. (2013). Breakthrough Therapy Designation.
[3] FDA. (2014). Lenvatinib (Lenvima) Approved for Differentiated Thyroid Cancer.
[4] FDA. (2016). Lenvatinib (Lenvima) Approved for Advanced Renal Cell Carcinoma.
[5] FDA. (2017). Lenvatinib (Lenvima) Approved for Renal Cell Carcinoma.
[6] FDA. (2020). Lenvatinib (Lenvima) and Pembrolizumab (Keytruda) Approved for Hepatocellular Carcinoma.
[7] Epub. 2014 Jun 12. Lenalidomide (Revlimid) and Lenvatinib (Lenvima) in the Therapeutic Pipeline: A Potential New Combination for the Treatment of Advanced Renal Cell Carcinoma
[8] FDA. (2020). Lenvatinib (Lenvima) and Pembrolizumab (Keytruda) Approved for Hepatocellular Carcinoma.
[9] DrugPatentWatch. (n.d.). Lenvima (lenvatinib).