U.S. FDA approves Rigel Pharma’s treatment for a type of leukemia
Dec 1 (Reuters) – Rigel Pharmaceuticals (RIGL.O) said on Thursday the U.S. health regulator has approved its drug for the treatment of patients with a type of leukemia, sending its shares up 14% in extended trading.
The Food and Drug Administration approved the drug, which will be sold under the brand Rezlidhia, for the treatment of a type of cancer of the blood and bone marrow called acute myeloid leukemia in patients with a susceptible genetic mutation.
Approval for the oral drug was supported by data from the company’s mid-stage study, which showed a 35% rate for complete remission of the cancer with a complete or partial recovery in blood count.
Rezlidhia will be the company’s second treatment to get approval from the FDA after Tavalisse for a rare bleeding disorder called immune thrombocytopenic purpura.
Rigel acquired the drug through a licensing agreement with Forma Therapeutics under which Rigel got the rights to develop, manufacture and commercialize Rezlidhia and the latter received an upfront payment of $2.0 million.
Forma can get an additional $17.5 million in certain near-term regulatory and first commercial sale milestones, as well as another $215.5 million on achievement of certain development and commercial targets.
Rigel said it plans to work with potential partners to further develop and commercialize the product outside the United States.
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