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CHMP refuses recommendation of Istodax( Celgene) for T-cell Lymphoma

Read time: 1 mins
Last updated:22nd Jul 2012
Published:22nd Jul 2012
Source: Pharmawand
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . The benefits with Xalkori are its important activity on ALK-positive NSCLC with an objective response rate of 60% (95% CI, 51% - 69%) and a median progression free survival (PFS) of 9.2 months (95% CI, 7.3 months � 12.7 months).

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