Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets

Alembic Pharmaceuticals on Thursday said it has received tentative approval from the US health regulator for its generic Ivosidenib tablets used in the treatment of certain types of cancer of bone marrow and bile duct.

The tentative approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Ivosidenib tablets of strength 250 mg, the company said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product Tibsovo tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier), it added.

The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

It is also indicated for adult patients with relapsed or refractory AML and adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated, Alembic Pharma added.

Ivosidenib tablets, 250 mg, have an estimated market size of USD 114 million in the 12 months ended March 2024, the company said citing IQVIA data.