Cipla gets USFDA nod for cancer drug

The company has received the final approval from the USFDA


Drug firm Cipla on Wednesday said it has received approval from the US health regulator for Lenalidomide capsule, a drug used to treat various types of cancer.

The company has received the final approval from the US Food and Drug Administration (USFDA) for the product in strengths of 5 mg, 10 mg, 15 mg and 25 mg, Cipla said in a regulatory filing.

Cipla's Lenalidomide capsules are therapeutic equivalent generic version of Bristol Myers Squibb's Revlimid (Lenalidomide) capsules.

Lenalidomide is an immunomodulatory prescription drug indicated for several hematological malignancies in adults such as multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings.

According to IQVIA (IMS Health), Revlimid capsules had sales of around USD 2.58 billion in the US for the 12-month period ended June 2022.

The product will be available for shipping soon, Cipla noted.

Shares of the company were trading 1.95 per cent up at Rs 1,061 apiece on the BSE.