IPSEN, a partner of Exelixis, Inc. (NASDAQ:EXEL), has announced the receipt of validation for a variation to the marketing authorization of cabozantinib (CABOMETYX) from the European regulator – EMA (European Medicines Agency). It is an addition for patients treated with advanced hepatocellular carcinoma (HCC) previously.
It is based on the encouraging results of phase 3 clinical trial of CELESTIAL worldwide. The drug has been proven for the overall survival of the patient. The patients treated with cabozantinib have shown positive results in overall survival when compared to the patients with advanced HCC, who were administered a placebo.
The CEO and President, Mr. Michael M. Morrissey, Ph.D. said the potential benefits of CABOMETYX for the patients, who were earlier treated for HCC, in the EU is very encouraging when few options are available for the treatment. It is a great achievement in partnership with IPSEN to provide the treatment using CABOMETYX for patients outside of the approved indication. It helps to increase the use of CABOMETYX for more patients.
The acceptance of the filing helped Exelixis to receive $10 million as per the terms of the license agreement and collaboration accord. As per the revenue recognition rules adopted by the company in Q1 2018, Exelixis will record the milestone payment from ISPEN in Q2 2018.
The drug cabozantinib has got the nod of US FDA on March 6, 2017, for the treatment of patients with advanced HCC. According to Exelixis, the independent committee monitoring the Celestial study has recommended stopping the trial for efficacy following the review.
Exelixis submitted a supplemental New Drug Application (sNDA) for CABOMETYX to the FDA on March 15, 2018, based on the findings of a Celestial study of treatment given to the patients with HCC.
If FDA approves the sNDA application of the drug, the physicians will be allowed to change the name of the previously approved product name.
It is estimated that over 700,000 deaths are reported every year due to liver cancer. The innovative drug provides a new life to the patients suffering from liver cancer. The drug is already being used for the treatment of other health complications like renal cell carcinoma.