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Lenvima for treatment of patients with progressive, differentiated thyroid cancer, approved by FDA

The FDA ( Food and Drug Administration ) has granted approval to Lenvima ( Lenvatinib ) to treat patients with progressive, differentiated thyroid cancer ( DTC ) whose disease progressed despite receiving radioactive iodine therapy ( radioactive iodine refractory disease ).
Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.
Lenvima was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition.
The drug also received orphan product designation because it is intended to treat a rare disease.

Lenvima’s efficacy was demonstrated in 392 participants with progressive, radioactive iodine-refractory differentiated thyroid cancer who were randomly assigned to receive either Lenvima or a placebo.
Study results showed Lenvima-treated participants lived a median of 18.3 months without their disease progressing ( progression-free survival ), compared to a median of 3.6 months for participants who received a placebo.
Additionally, 65% of participants treated with Lenvima saw a reduction in tumor size, compared to the 2% of participants who received a placebo.
A majority of participants randomly assigned to receive the placebo were treated with Lenvima upon disease progression.

The most common side effects of Lenvima were high blood pressure ( hypertension ), fatigue, diarrhea, joint and muscle pain ( arthralgia / myalgia ), decreased appetite, decreased weight, nausea, inflammation of the lining of the mouth ( stomatitis ), headache, vomiting, excess protein in the urine ( proteinuria ), swelling and pain in the palms, hands and/or the soles of the feet ( palmar-plantar erythrodysesthesia syndrome ), abdominal pain and changes in voice volume or quality ( dysphonia ).

Lenvima may cause serious side effects, including cardiac failure, blood clot formation ( arterial thromboembolic events ), liver damage ( hepatotoxicity ), kidney damage ( renal failure and impairment ), an opening in the wall of the stomach or intestines ( gastrointestinal perforation ) or an abnormal connection between two parts of the stomach or intestines ( fistula formation ), changes in the heart’s electrical activity ( QT interval prolongation ), low levels of calcium in the blood ( hypocalcemia ), the simultaneous occurrence of headache, confusion, seizures and visual changes ( reversible posterior leukoencephalopathy syndrome ), serious bleeding ( hemorrhage ), risks to an unborn child if a patient becomes pregnant during treatment, and impairing suppression of the production of thyroid-stimulating hormone.

The most common type of thyroid cancer, differentiated thyroid cancer, is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism.
The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014. ( Xagena )

Source: FDA, 2015