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The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. Five years after the initial accelerated approval, you should have a definitive answer, said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not." The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce
Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America. The company in partnership with Pharmascience Inc. has received approval from the US Food and Drug Administration (FDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, it said in a statement. The Mumbai-based drug maker's product is a generic version of Bristol-Myers Squibb Company's Sprycel tablets. As per IQVIA MAT data, Dasatinib tablets had an estimated annual sale of USD 1,569 million in the US. Shares of Lupin settled at Rs 662.50 apiece, up 1.49 per cent on the BSE.