FDA approves new cancer drug Copiktra (duvelisib) for use in CLL and SLL adult patients
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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lymphoma is the most common type of blood cancerThe three types of blood cancer treated by Copiktra are inert non-Hodgkin lymphoma (indolent non-Hodgkin lymphoma)yesterday (September 25), the U.SFDA(announced) that Verastem Oncology(duvelisib) to treat adult patients with recurrent/incurable chronic lymphatic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least two pre-treatment treatmentsat the same time the FDA approved Copiktra to treat adult patients with recurrent/incurable follicles (FL) who had received at least two pre-treatment treatmentsCopiktra, developed by VerastemVerastem, is an innovative oral inhibitor of PI3K protein kinaseIt can inhibit the activity of both PI3K-niand and PI3K-nichThese two protein kinases help support the survival and growth of cancerous B cellsCopiktra's new drug application was eligible for fda-granted reviewPreviously, Copiktra was also eligible for fast-track and orphan medicine sedated by the FDArelated studiesapproval for treatment of CLL and SLL are based on a multicenter random open label of the 3st Phase 3 ClinicalTrial(which compares the efficacy of duvelisib with the current standard therapy for treating CLL and SLL patients with recurrent/incurable CLL or SLL)Of the 196 patients who had received at least two treatments, the non-progressive survival period was 16.4 months in the duvelisib group and 9.1 months in the active control groupTotal mitigation rates (ORR) were 78% (duvelisib group) and 39% (active control group), respectivelytreatment FL approval is based on a single-arm multi-center Phase 2 clinical trialEighty-three FL patients who developed resistance to ritusximab and chemotherapy or radiotherapy were treated with duvelisibThe ORR was 42%, with 41% of the patients in partial remission and 1 patient in total remissionamong patients who received remission, 43% had remission periods of more than 6 months, and 17% had remission periods of more than 12 months
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