Natco Pharma Gets USFDA Tentative Approval for Cancer Drug Erdafitinib

In its regulatory filing, NATCO stated that the tentative approval marks a key regulatory milestone for the company in the oncology segment of the US generics market. The product is indicated for the treatment of adult patients with locally advanced, unresectable, or metastatic urothelial carcinoma who harbor susceptible FGFR3 genetic alterations and have experienced disease progression following at least one prior line of therapy.

According to the company, Erdafitinib is a targeted therapy used in a specific subset of bladder cancer patients, addressing a critical unmet medical need in oncology. The tentative approval allows NATCO to move closer to commercializing the product in the United States, subject to the resolution of regulatory and patent-related requirements.

NATCO Pharma noted that Erdafitinib tablets recorded estimated sales of approximately USD 60 million in the US market for the 12-month period ending September 2025, based on industry sales data. The company highlighted that this market potential aligns with its strategy of focusing on limited-competition molecules in the US.

NATCO Pharma Limited, headquartered in Hyderabad, is engaged in the development, manufacturing, and distribution of generic and branded pharmaceuticals, specialty products, active pharmaceutical ingredients, and crop protection products. The company is a research-driven organization and is recognized as a leading oncology player in targeted therapies in the domestic market.

The company operates nine manufacturing facilities and two research and development centers in India, with its plants approved by several global regulatory authorities including the US FDA, Brazil’s ANVISA, Health Canada, and the World Health Organization, enabling it to supply products to more than 50 countries worldwide.

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