Sandoz Pvt. Ltd. (Novartis India)
The United States Food and Drug Administration (USFDA) approved Cometriq (Cabozantinib) for the treatment of malignant medullary thyroid cancer. Cometriq is manufactured by San Francisco-based drug manufacturing company, Exelixis.
According to USFDA statement, Cometriq is a kinase activity inhibitor that antagonizes the physiological activities of proteins that are involved in cell cycle and differentiation. The drug should be taken at least two hours after food intake or the patient should not take food at least for one hour, post-administration of Cometriq to facilitate gastrointestinal absorption, FDA explained.
In United States alone, the medullary thyroid cancer accounts for about 4% of total thyroid cancers that claim 56000 lives every year. The malignancy in calcium homeostasis regulating cells results, in abnormal calcium homeostasis and its associated disorders, according to USFDA press release.
The manufacturer conducted initial phases of placebo-controlled clinical trials with 330 volunteers to determine the safety and effectiveness in human volunteers with medullary thyroid cancer. When compared to placebo group, improved survival rate of an average of 11.2 months without tumor progression was observed in the Cometriq-treated patients. However, an average of four months was observed in the placebo group. The FDA announced that Cometriq can delay the tumor progression but not the survival rate significantly.
The drug is to be dispensed with a boxed label warning of iatrogenic colon bleeding events that can be severe or even fatal, FDA warned.
The clinical trial data reported less serious and common adverse events such as anorexia, GI disturbances with diarrhoea, stomatitis, swelling and redness of fingers and/or toes and unexplained weight loss.
Ranbaxy Laboratories Limited