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On Monday, the U.SFDA approved Roche Polivy (formerly known as polatuzumab), in combination with rituximaandiandand and chemotherapy benzodiazepines, for patients with diffuse large B-cell lymphoma who had previously failed or relapsed in at least two previous treatmentsNow that Roche's lucrative cancer-heavy drugs are increasingly under attack from a growing number of biosimilars, the company has now received FDA approval for treatment of diffuse large B-cell lymphoma, which appears to have become the only effective treatment for patientsPreviously, the FDA approved the Polivy portfolio priority review and breakthrough treatment designationPolivy's active trial results in phase 1b/2 eventually gave it the green light to regulateThe results showed that the combination was better than the usual treatment therapy for benzoisandand Rituxan pairingsIn this trial, 40 percent of patients used the Polivy combination to achieve a full efficacy response, compared with only 18 percent in the benzoystin and Rituxan groupsAt the end of the treatment process, 45 percent of patients in the Polivy combination had an objective response, compared with only 18 percent in the benzomostin and Rituxan groupsRoche Genetec's chief marketing officer, Sandra Horning, said in a press release that the Polivy approval "will provide an immediate treatment option for patients of this type of treatment and also fill the gap in new treatments for invasive diseases." "The diffuse large B-cell lymphoma, short for DLBCL, is the most common non-Hodgkin lymphomaestimates that more than 18,000 new DLBCL cases are reported each year in the United StatesAlthough many patients' conditions can be effectively controlled after initial treatment, 30%-40% of patients will eventually relapseGiven the progression of the disease, Horning said, "treatment options become very limited when patients are still difficult to cure or relapse after trying multiple treatment options." "
" antibody conjugate dissotomy is a new type of cancer-targeted therapyUnlike traditional chemotherapy, it targets specific cells," said DrRichard Pazdur of the FDA's Center for Drug Evaluation and Research"
Currently, Roche's Rituxan, Avastin and Herceptin are increasingly under the threat of competition from biosimilars in the United States and elsewhere The drugs generated more than $10 billion in sales in the U.S market last year, but Roche expects the three drugs to face a major bife of biosimilars in the U.S market by the end of the year , however, Roche doesnot appear to have been knocked down by the generics In response to competition, the company has launched several new drugs, including the multiple sclerosis drug Ocrevus, which is on the market for the first year, and haemophilia treatment Hemlibra reference source: 1, Roche snags first-in-class FDA nod for lymphoma drug Polivy 2, FDA's first family chemoathe regimen for patients with the reiplapsed or refractory diffuse large B-cell lymphoma