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Roche: FDA grants accelerated approval to leukaemia drug

(CercleFinance.com) - The FDA granted accelerated approval to Roche's Venclexta to treat people with newly-diagnosed acute myeloid leukaemia, or those who are ineligible for intensive induction chemotherapy.


The US Food and Drug Administration has granted accelerated approval to Venclexta in combination with a hypomethylating agent, or low-dose cytarabine, for the treatment of people with newly-diagnosed acute myeloid leukaemia, who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions, Roche said.

Venclexta is being developed with AbbVie.

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