FDA. US: The U.S. Food and Drug Administration today 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).
The
most common type of thyroid cancer, DTC 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. Lenvima is a kinase inhibitor, which works by blocking
certain proteins from helping cancer cells grow and divide.
“The
development of new therapies to assist patients with refractory disease
is of high importance to the FDA,” said Richard Pazdur, M.D., director
of the Office of Hematology and Oncology Products in the FDA’s Center
for Drug Evaluation and Research. “Today’s approval gives patients and
healthcare professionals a new therapy to help slow the progression of
DTC.”
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 is being approved approximately two months ahead
of the prescription drug user fee goal date of April 14, 2015, the date
when the agency was scheduled to complete its review of the application.
Lenvima’s
efficacy was demonstrated in 392 participants with progressive,
radioactive iodine-refractory DTC 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 percent
of participants treated with Lenvima saw a reduction in tumor size,
compared to the two percent 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.
Lenvima is marketed by Woodcliff Lake, New Jersey-based Eisai Inc.
The
FDA, an agency within the U.S. Department of Health and Human Services,
promotes and protects the public health by, among other
things, assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use,
and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating tobacco
products.