U.S. FDA approves Rigel Pharma's treatment for a type of leukemia (updated)

Rigel Pharmaceuticals

01/12/2022 23:30

(Adds details from company statement, background)
       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.
  
 (Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))