Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Phar­ma bought olu­tasi­denib from For­ma Ther­a­peu­tics, it ac­quired a drug that al­ready se­cured a PDU­FA date at the FDA — for Feb­ru­ary 2023. But reg­u­la­tors are ready to give their OK soon­er than that.

The FDA has ap­proved the IDH1 in­hibitor as a treat­ment for adult pa­tients with re­lapsed or re­frac­to­ry acute myeloid leukemia who have a sus­cep­ti­ble IDH-1 (isoc­i­trate de­hy­dro­ge­nase-1) mu­ta­tion as de­tect­ed by an FDA-green­lit test. Rigel will mar­ket it as Re­zlid­hia.

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