Sun Pharma presents Clinical Insights of ODOMZO, LEVULAN KERASTICK for Treating People With Risk of Skin Cancer

Mumbai: Sun Pharmaceutical Industries Ltd. recently announced that one of its wholly-owned subsidiaries presented data analyses for two of its specialty medicines – ODOMZO (sonidegib) and LEVULAN KERASTICK (aminolevulinic acid HCl) + BLU-U – from its dermatology portfolio, providing insights to healthcare providers treating patients who have or are at risk for different types of skin cancer. These data analyses were presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020, June 12-June 14.

One in every three cancers diagnosed is a skin cancer, with the most common forms being basal cell carcinoma and squamous cell carcinoma, collectively known as nonmelanoma skin cancers.1,2 It is estimated that nonmelanoma cancers affect more than three million Americans each year, a rate that has more than doubled in the last 50 years.1,2 Both of these types of cancers are curable if detected early and treated properly.

"With incidence rates increasing and more treatment options needed, we are committed to providing clinical support for our medicines and helping address the needs of patients who are impacted by the different stages of skin cancer," said Nicholas Squittieri, M.D., Senior Medical Director, Sun Pharma. "The evidence presented at the AAD Virtual Meeting Experience offers important insights and guidance to dermatology healthcare providers who are using ODOMZO and LEVULAN in their daily clinical practice."

ODOMZO, a hedgehog inhibitor, is used to treat adults with locally advanced basal cell carcinoma (laBCC) that has returned following surgery or radiation or that cannot be treated with surgery or radiation. Long-term analyses of the BOLT study confirmed that treatment with ODOMZO provided clinically meaningful outcomes to patients with laBCC who were taking common concomitant medicines, such as medicines for cardiovascular, inflammatory and auto-immune diseases.3,4 The safety profile for ODOMZO in these patients who were an average age of 67 years old was manageable and consistent with overall findings from the BOLT study.

"Our research showed that the positive efficacy and safety benefits of ODOMZO were not impacted by commonly used medicines like statins or nonsteroidal anti-inflammatory drugs that some patients may need to take simultaneously to treat other health conditions," said one of the lead study investigators Prof. Reinhard Dummer, M.D., Vice-Chairman of the Department of Dermatology, University Hospital of Zurich, Switzerland. "Since basal cell carcinoma is more commonly found in older adults, these insights are reassuring for dermatologists who are considering ODOMZO for their older patients."

LEVULAN KERASTICK for topical solution, 20%, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is used to treat minimally to moderately thick actinic keratoses of the face, scalp or upper extremities, which the Skin Cancer Foundation classifies as precancerous skin growths that if left untreated may turn into squamous cell carcinoma. While only about 10% of actinic keratoses become cancerous, the majority of squamous cell carcinoma cases start as actinic keratoses.

"Effectively treating actinic keratoses is the only way to prevent their cancerous progression," said lead investigator Brian Berman, M.D., Ph.D., Emeritus Professor, University of Miami Department of Dermatology and Cutaneous Surgery and Co-Director of the Center of Clinical and Cosmetic Research, Aventura, FL. "We are continually researching ways to treat actinic keratoses and our analysis of LEVULAN KERASTICK plus BLU-U offers our dermatology colleagues clinical insights and confidence to use this treatment for people with minimally to moderately thick actinic keratoses not only on the face and scalp but also on the forearms."

The post hoc analysis offered more detailed insights into the benefits of photodynamic therapy (PDT) with LEVULAN KERASTICK + BLU-U to treat minimally to moderately thick actinic keratoses on the upper extremities, meaning the arms from elbows to base of the fingers:

• Significantly Greater Clearance of Lesions – At 12 weeks, the mean clearance rate of all lesions treated with PDT using LEVULAN KERASTICK + BLU-U was 80.6% after one or two treatments compared to 45.5% treated with placebo PDT
• Significantly Greater Clearance of Cumulative Disease Area – Eight out of 10 patients (82.4%) treated with PDT using LEVULAN KERASTICK + BLU-U were 100% clear at 12 weeks after one or two treatments compared to four out of 10 patients (42.6%) treated with placebo PDT
• Large Lesion Clearance – More than half of patients treated with PDT using LEVULAN KERASTICK + BLU-U experienced complete clearance of larger lesions (70.6% with lesions 25–36 mm2 and 59.5% with lesions ≥36 mm2)
• No Safety Profile Concerns Raised – PDT with LEVULAN KERASTICK + BLU-U was well tolerated, with no clinically significant adverse events reported or discontinuations due to adverse events.

LEVULAN KERASTICK is the only photodynamic therapy medicine approved by the US FDA for use on the upper extremities.

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