Zydus Lifesciences bags USFDA tentative nod for breast cancer drug Palbociclib

Ahmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg (USRLD: Ibrance Tablets, 75 mg, 100 mg, and 125 mg).

Palbociclib is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells.

The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad (India).

Palbociclib Tablets, 75 mg, 100 mg, and 125 mg had annual sales of USD 3.3 bn in the United States (IQVIA MAT April 2023). The group now has 373 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the company had received final approval from the US health regulator to market Fulvestrant Injection, used in the treatment of breast cancer.

Breast cancer arises in the lining cells (epithelium) of the ducts (85%) or lobules (15%) in the glandular tissue of the breast. Initially, the cancerous growth is confined to the duct or lobule (“in situ”) where it generally causes no symptoms and has minimal potential for spread (metastasis).

Over time, these in situ (stage 0) cancers may progress and invade the surrounding breast tissue (invasive breast cancer) then spread to the nearby lymph nodes (regional metastasis) or to other organs in the body (distant metastasis).

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