New label for cancer drug sold by Novartis

India’s Sun Pharmaceutical Industries has announced that it has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo (sonidegib), an oral hedgehog inhibitor for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

The new label now incorporates long-term data from the 30-month analysis of BOLT trial, in which Odomzo continued to show sustained durable tumor response of 26 months with no new safety concerns. Sun Pharma acquired the drug from Novartis in December 2016.