Odomzo gets FDA’s Approval

The US Food and Drug Administration has given green signal to a new drug meant for patients diagnosed with advanced basal cell carcinoma, a common cancer in skin’s top layer. The drug, Odomzo, is meant for patients whose cancer has not spread to other body parts and is not treatable with other treatments.

It is a once-daily pill and has been designed to inhibit the Hedgehog pathway. The drug’s efficacy was tested in a clinical study having 66 people. The FDA stated that 58% of people treated with 200 mg of Odomzo witnessed their tumors shrink or disappear.

It shall, however, be noted that the drug also pose side effects that include muscle spasms, alopecia, dysgeusia, fatigue, nausea, myalgia, diarrhea, and weight loss. The drug also contains a boxed warning that it may cause death and many birth effects can take place.

Therefore, it has been suggested that women who want to start taking this drug should check their pregnancy status. The agency has also stated that both males and females who take the drug should use contraception.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said, “Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last three years”.

The drug has the ability to stop or reduce the growth of cancerous lesions by suppressing a molecular pathway. The drug, chemically known as sonidegib, is developed by Swiss drugmaker Novartis AG. The company is yet to reveal about the drug’s price.