Alembic Pharma Gets USFDA Nod for Cancer Drug

Alembic Pharmaceuticals has received USFDA approval for its generic cancer treatment drug, Nelarabine Injection. The drug is intended for patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. The company's shares saw a slight uptick following the announcement.

Alembic Pharmaceuticals on Friday announced that it has received approval from the US health regulator to market its generic cancer treatment drug.

The firm's Nelarabine Injection (250 mg/50 mL) has gained final approval from the US Food and Drug Administration (USFDA). This product is therapeutically equivalent to Sandoz Inc's Arranon Injection, according to a regulatory filing by Alembic Pharmaceuticals.

Nelarabine is used for treating patients suffering from T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, especially those whose diseases have relapsed or haven't responded to at least two chemotherapy treatments. IQVIA reports that the market size for Nelarabine Injection is estimated at USD 23 million for the twelve months ending March 2024.

This approval brings Alembic’s cumulative total of USFDA-approved abbreviated new drug applications (ANDAs) to 211. Following the announcement, shares of Alembic Pharmaceuticals were trading at Rs 1,222 apiece, up by 0.53 per cent on the BSE.