Sun Pharma gets FDA approval for new label for Odomzo
- September 24, 2017
- Drugs
Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo (sonidegib).
Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Odomzo was approved by the FDA in July 2015, based on 12-month follow-up results from the pivotal Phase II Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) clinical trial, a multicenter, double-blind study involving 194 patients with laBCC and 36 patients with metastatic basal cell carcinoma (mBCC). 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.
The rigor of the BOLT study design and results analyses should reassure patients and physicians that Odomzo can treat this devastating and sometimes disfiguring disease over the long term.
