FDA approves Novartis drug Odomzo
pharmafile | July 27, 2015 | News story | Sales and Marketing |Â Â Novartis, Odomzo, basal cell carcinoma, skin cancerÂ
The FDA has given the Swiss firm the go-ahead to market its drug for skin cancer.
Odomzo (sonidegib, formerly LDE225) is used as a treatment for adults with locally advanced basal cell carcinoma (laBCC) that has returned following surgery or radiation therapy, or those who are not chosen for surgery or radiation therapy.
“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,” says Bruno Strigini, president of Novartis Oncology.
“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.”
The approval of Odomzo is based on studies in which people with laBCC who were treated with Odomzo 200 mg were followed for roughly 12 months, unless they discontinued treatment earlier. The objective response rate (ORR) – the proportion of patients who showed a durable response to treatment – was 58%, consisting of 5% of people who showed a complete response (CR) and 53% who showed a partial responses (PR).
Basal call carcinoma happens when abnormal, uncontrolled growths or lesions start to grow in the skin’s basal cells, which line the deepest layer of the epidermis (the outermost layer of the skin). The condition accounts for more than 80% of non-melanoma skin cancers.
- The Novartis Foundation has confirmed several new members of its board of trustees, including a new chairman in Dr Joerg Reinhardt, who is also chairman of the Novartis board of directors. He will serve as chairman of the foundation’s board of trustees, along with new members Professor Peter Piot of the London School of Hygiene and Tropical Medicine, Dr Rebecca Weintraub of Harvard Medical School, and Rainer Boehm from Novartis Pharmaceuticals.
Yasmita Kumar
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