The drug is approved for adults with laBCC, which has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
The approval was based on data from an international, multi-center, double-blind, randomized, two-arm, non-comparative Phase II trial (BOLT) which showed durable objective response rate (ORR) in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC).
The trial’s primary endpoint was ORR of patients treated with Odomzo 200mg and 800mg, defined as the proportion of patients with confirmed complete or partial tumor response, or shrinkage, as measured by a central review committee.
Novartis Oncology president Bruno Strigini said: "The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring.
"Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients."
Patients with laBCC treated with Odomzo 200mg were followed for at least 12 months unless discontinued earlier.
The company noted that among the 38 patients with an objective response, 31 patients have ongoing responses ranging from at least 1.9 to 18.6 months and the median duration of response has not been reached.