Cipla receives US FDA approval for Nilotinib Capsules to treat Chronic Myeloid Leukemia (CML)

Cipla has received final approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Nilotinib Capsules in 50 mg, 150 mg, and 200 mg dosages. Nilotinib is indicated for the treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML), a cancer that affects the bone marrow and blood.

This approval marks a significant milestone for Cipla, further expanding the pharmaceutical giant’s oncology portfolio. The company plans to launch Nilotinib in the United States during the financial year 2025-26, providing an important new treatment option for CML patients in the US market.

Nilotinib, available in capsule form for oral consumption, is used to treat Philadelphia Chromosome Positive Chronic Myeloid Leukemia, a form of leukemia that primarily affects adults, with the average age of diagnosis being 64.

The American Cancer Society estimates that in 2025, approximately 9,560 new CML cases will be diagnosed in the US, with about 1,290 fatalities.

Meanwhile, Cipla’s share price rose nearly 1% on the NSE, settling at ₹1,487.15. Over the past year, the stock has delivered a return of nearly 2%.

For Q3, Cipla reported a revenue of ₹7,073 crore, marking a 7% year-on-year growth and surpassing the expected ₹6,870.2 crore.

Earnings Before Interest, Tax, Depreciation, and Amortisation (EBITDA) grew by 14% year-on-year to ₹1,989 crore, exceeding the expected ₹1,748 crore. The company’s EBITDA margin expanded by 200 basis points to 28%, up from 26% in the same period last year.

Sales from Cipla’s largest market, the US, declined by 2% year-on-year to $226 million, though this was still better than the anticipated $218 million.