The US Food and Drug Administration US (FDA) has approved the lurbinectedina , a drug developed in Spain that will be marketed under the brand Zepzelca for treatment of the cancer of small cell lung metastatic, the most aggressive of its kind. As reported by the Spanish company PharmaMar, lurbinectedin is expected to be commercially available in the US. USA at the beginning of next July. In all honesty, I think it is something historic. Both in the fight against cancer and within the milestones of our own company and the scientific community “in Spain , the company president, José María Fernández Sousa, told the ABC newspaper.
With this approval PharmaMar will receive royalties on net sales of lurbinectedin, which ranges from high double digits to a maximum of 30%. Additionally, PharmaMar will enter a payment of more than 88 million euros (100 million dollars) and may receive up to an additional 132.6 million euros (150 million dollars) once full approval occurs. “This is the first second-line approval of this type of tumor in 24 years. So has that historical character this approval , “said the leader of the directory to the middle of Spain .
He added that the only drug that had been approved so far is topotecan, which “in practice is only used in 23% of cases, as its management is very complicated.” “The rest are treated with products not approved for that indication, which shows the lack of adequate treatment for these patients” with cancer , he said. The FDA’s Accelerated Approval program allows conditional approval of a drug that meets an unmet medical need for a serious, life-threatening disease or condition.