The approval was based on data from the randomized, double-blind, multi-center Phase II BOLT study in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC).
The trial showed that in patients with laBCC treated with Odomzo 200mg, the objective response rate (ORR) was 56% per central review and 71% per investigator review.
University of Zurich Department of Dermatology professor and vice chairman Reinhard Dummer said: "I have seen first-hand the devastating impact advanced basal cell carcinoma can have on those living with the disease.
"As the lesions are usually highly visible and located predominantly on the face, they can impact patients both physically and emotionally.
"The approval of Odomzo brings new hope in the form of a non-invasive option to help treat this disfiguring and potentially life-threatening disease."
The company noted that median duration of response per central review has not been reached, while the median progression-free survival (PFS) was 22 months per central review and 19 months per investigator review.
Odomzo, a smoothened inhibitor, is already approved in the US, Australia and Switzerland, with additional regulatory filings underway across the world.
Novartis Oncology president Bruno Strigini said: "We are pleased to have a new treatment option for European patients living with advanced basal cell carcinoma.
"This milestone follows the recent approval of Odomzo in the US and is the latest example of our commitment to precision oncology and developing targeted treatments to address unmet needs."