A rare form of thyroid cancer, medullary thyroid carcinoma, began in the cells make calcitonin, calcium levels in the hormonal regulation of the blood and bones. Occurrence of medullary thyroid carcinoma with a specific gene mutation can lead to at least one type of endocrine system tumors, including thyroid cancer among people with no genetic fault, it may occur spontaneously in the family, FDA (Food and Drug Administration).
Medullary thyroid cancer can spread to the lymph nodes, lungs and bones. Current treatments include surgical removal of the thyroid, and lymph nodes in the neck.
According to the U.S. National Cancer Institute in the United States, about 56,460 people were diagnosed with thyroid cancer this year, and 1,780 are expected to die from the disease in the same period.
1 25 of thyroid cancer medullary thyroid carcinoma.
Dr. Richard Pazdur, MD, director of the Office of FDA Drug Evaluation and Research Center for Hematology and Oncology Products, said:
"Cometriq second drug approved for the treatment of medullary thyroid carcinoma reflects FDA's commitment to the development and approval of drugs for the treatment of rare diseases in the past two years, today's approval, and approval of Caprelsa 2011 April, this rare patients with difficult-to-treat disease with limited treatment options. "
Cometriq submit institutions approved within six months after the review, according to the FDA's priority review process. The accelerated approval process of this type is designed for drug treatment of significant progress, or provide some sort of treatment is not enough. Cometriq is used to treat a rare disease, it also received the name of "orphan" products. "
cometriq kinase inhibitors.
Abnormal kinase protein involved in the growth and development of medullary cancer cells. cometriq kinase inhibitors. Cometriq when you should fast for at least two hours before 1 hour. The recommended dose is 140 mg orally, once daily (80 mg capsules plus three 20 mg capsules). Should not be taken food Cometriq.
FDA review of clinical trials of the safety and efficacy of Cometriq, involving 300 participants, all of them check the data with medullary thyroid carcinoma. Progression-free survival period increased significantly in the last Cometriq. In some cases, a reduction in tumor size.
Here is some data, Cometriq compared with placebo advantages:
Those who tumor growth in Cometriq, survival of 11.2 months (average)
No tumor growth, while the placebo group of patients survive for four months (average)
Lasted nearly 15 months, an average of 27%, while the placebo group tumor reduction
Participants in the placebo experienced tumor shrinkage
Cometriq contains a boxed warning to tell doctors and patients with serious and life-threatening bleeding and perforation, the risk of colon fistula.
The the of patients taking Cometriq reported side effects include: constipation, abdominal pain, worsening hypertension, high blood pressure, bad taste, loss of hair color, gray hair, oral pain, fatigue, nausea, loss of appetite, weight loss, hand-foot levy (swelling of the fingers and toes), pain, redness, swelling, pain and inflammation of the mouth, and diarrhea.
Cometriq sales company Exelixis
Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis, said:
"Of approved COMETRIQ patients progress, metastatic medullary thyroid carcinoma, their families, and their doctors, as well as an important milestone in the company Exelixis, we are very grateful to participate in development of clinical COMETRIQ, many patients who in the MTC, we are committed as soon as possible to make this important new therapy. "
Endocrine Naguib Samaan Distinguished Professor at the MD Anderson Cancer Center, Steven I. Sherman, MD, explained, until the introduction of targeted therapy, not much progress has been in the treatment of advanced medullary thyroid carcinoma. He added: "We are very pleased to give these patients a new treatment method has been proved progression-free survival was significantly increased nearly three times in the clinical trials of a new treatment method to improve patient care, the potential availability of results changed the the MTC treatment of landscape, and provides a new way to control this disease patients and physicians. "
