Sun Pharmaceutical Industries announced in September the FDA has approved a new label for sonidegib (Odomzo, Novartis), an oral hedgehog inhibitor indicated for the treatment of adults with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or for patients 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 sonidegib continued to show sustained durable tumor response of 26 months with no new safety concerns.
Sonidegib was approved by the FDA in July 2015 based on a 12-month follow-up double-blind clinical trials of 194 patients with laBCC and 36 patients with metastatic basal cell carcinoma (mBCC).
With 30 months of follow-up patients with laBCC continued to demonstrate sustained antitumor activity and prolonged clinical benefit. Among patients treated with the 200-mg dose (approved dose), the ORR was 56%. The median duration of response was 26.1 months.
As in the primary (12 month) analysis, the 200-mg dose exhibited a low rate of grades ¾ adverse events (AEs; 43.0%) and AEs leading to discontinuation (30.4%).
This treatment works by inhibiting a molecular pathway, known as the hedgehog signaling pathway, which is implicated in the origination and development of basal cell carcinoma when the pathway malfunctions. By blocking the hedgehog pathway, the treatment may halt or slow the growth of cancerous lesions.