EU Approves Cabozantinib for Metastatic Medullary Thyroid Carcinoma

EU Approves Cabozantinib for Metastatic Medullary Thyroid Carcinoma

CabozantinibThe end of March 2014 brought exciting news from the EU with the announcement of their approval of Cabozantinib for unresectable medullary thyroid carcinoma. Known as the brand name Cometriq and marketed by Exelixis, Cabozantinib works by inhibiting the activity of MET, RET and VEGFR tyrosine kinases. Cases of medullary thyroid carcinoma are virulent and affect roughly one out of every twenty five patients with thyroid cancer. MTC is considered an uncommon form of thyroid cancer and is believed to be genetic in origin for some patients. Oftentimes medullary thyroid cancer quickly spreads to the lungs, bones and lymph nodes. The National Cancer Institute estimates that a little over 56,000 people will be diagnosed with a form of thyroid cancer this year, and almost 2000 of these patients will not survive their diagnosis. The use of Cabozantinib to treat the patient population with MTC is crucial as this specialty drug is indicated specifically for patients in whom an RET mutation status is negative or unknown. The advent of a treatment opportunity with Cabozantinib offers this group of patients with metastatic MTC new hope.

Cabozantinib (Cometriq) was approved in the United States for the treatment of advanced and unresectable MTC in November 2012. Both the U.S. and the EU based their approvals on positive data from a Phase 3 clinical trial coined EXAM. The EXAM trial was international and multi center and included 330 patients with metastatic medullary thyroid carcinoma. This randomized and double- blinded trial showed that the use of Cabozantinib in patients significantly improved progression-free survival as compared to a placebo. Cabozantinib, as Cometriq, is available in 20 milligram and 80 milligram capsules. The capsules should be swallowed whole on an empty stomach, with a full glass of water. Serious side effects may occur, but many patients found Cabozantinib to be safe and tolerable.

LGM Pharma provides the API Cabozantinib for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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