NMPA accepts new indications application for the anti-cancer drug Lenvima (Lewema, Lenvatinib, Lenvastini)
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Eisai, a Japanese pharmaceutical company, announced that thecompany's new application for treatment of differentiated thyroid cancer (DTC)(http://the anti-cancer drug Lenvima (Levatinib, Lunvatini) has been accepted by the NationalMedicines(http://Regulatory Authority (NMPA)The applicationbased on data from the global SELECT study (Study 303)the study, conducted in patients with radioactive iodine incurable differentiated thyroid cancer, showed a statistically significant extension of the non-progressive survival of the Lenvima treatment group compared to the placebo group (median PFS: 18.3 months vs3.6 months; HR 0.21(99% CI: 0.14-0.31) ;p 0.001)in addition,, patients were able to obtain rapid treatment remission after receiving Lenvima administration, with a median time of 2.0 months for the first objective remissionCompared to the placebo group, the Lenvima treatment group also had a statistically significant improvement in total remission rate (ORR) (64.8% vs 1.5%, p 0.001)In particular, 1.5% of patients in the Lenvima treatment group received complete remission and the placebo group was zerosafetystudies, the most common adverse events associated with Lenvima treatment were high blood pressure, diarrhea, fatigue or fatigue, loss of appetite, weight loss, and nausea The application can be submitted in advance using the results of the SELECT study, although the current phase III clinical trial
(
http:// Study 308) (Study 308) for the treatment of patients with radioactive iodine refractory refractory differentiated thyroid cancer in China is ongoing
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