Alembic Pharmaceuticals Gains Tentative USFDA Nod for Cancer Drug

Alembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Ivosidenib tablets, designed to treat certain cancers of the bone marrow and bile duct. This product is deemed equivalent to Servier Pharmaceuticals' Tibsovo tablets. The estimated market for the drug is USD 114 million as of March 2024.

Alembic Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its generic Ivosidenib tablets, a treatment option for specific bone marrow and bile duct cancers.

The USFDA's tentative nod pertains to the Abbreviated New Drug Application (ANDA) for 250 mg Ivosidenib tablets, which are therapeutically equivalent to Tibsovo tablets by Servier Pharmaceuticals LLC.

Indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) who are 75 or older, or those unable to undergo intensive chemotherapy, the drug also serves adult patients with relapsed/refractory AML or metastatic cholangiocarcinoma. As of March 2024, the market for Ivosidenib tablets is valued at USD 114 million, according to IQVIA data.