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B-Raf Inhibitor Receives FDA Orphan Drug Designation for Treatment of EGFRI-Induced Acneiform Rash


Most patients undergoing EGFRI treatment for cancer will develop acneiform lesions, yet no drug is currently approved by the FDA for their prevention or treatment.

Araki Illustrations/Adobe Stock

Araki Illustrations/Adobe Stock

Lutris Pharma today announced that its compound LUT014 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA)’s Office of Orphan Products Development.1

LUT014, a novel topically applied B-Raf inhibitor, is now designated for the treatment of EGFRI (Epidermal Growth Factor Receptor Inhibitor)-induced acneiform rash.

The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition, and this designation is a separate process from seeking approval or licensing.2 Although EGFRI-induced acneiform lesions are not rare (they have been estimated to occur in 50% to 100% of patients receiving EGFRIs),3 currently no drug or treatment is approved by the FDA for their prevention or treatment, according to Lutris.

Acneiform lesions can impact patients’ quality of life and affect adherence to EGFRI therapy, the company states.

"As a result of the dermal toxicity caused by EGFR inhibitors, many patients [receiving EGFRI treatment] do not receive the optimal treatment against their cancer, either due to dose reduction or even discontinuation, caused by the rash," said Antoni Ribas, MD, PhD, chairman and founder of Lutris, in a press release.

"Importantly, results from our phase 1 trial of LUT014 in patients with metastatic colorectal cancer who had developed grade 2 rash demonstrated the safety of the approach as well as provided preliminary favorable efficacy results and a dose response. We look forward to reporting results from the ongoing phase 2 randomized clinical trial of LUT014 in treating skin toxicities caused by EGFR inhibitors in the future."

According to the Lutris website, preliminary data from the phase 2 study demonstrate efficacy of LUT014. The company hypothesizes that “administration of B-Raf inhibitor LUT014 topically to a regimen of EGFR inhibitors in these patients reversed its inhibitory effect on downstream proteins in the skin cells and decreased the associated acneiform lesions induced by the EGFR inhibitors.”

The Orphan Drug Designation for LUT014 also qualifies Lutris for incentives “including tax credits for qualified clinical trials, exemption from user fees, and potentially 7 years of marketing exclusivity for LUT014, should it gain approval for the treatment of EGFRI inhibitor acneiform rash,” according to the company.

Lutris announced last week publication of phase 1/2 data in the Journal of the American Academy of Dermatology International wherein LUT014 demonstrated positive effects in radiation-induced dermatitis among patients with breast cancer.4

This randomized trial included 20 patients with breast cancer and radiation-induced dermatitis. The patients were randomized to receive topical LUT014 or a placebo for a 28-day treatment period.

Investigators found that 6 of 8 patients who had developed grade 2 radiation dermatitis exhibited complete resolution upon treatment with LUT014. After a 28-day treatment period, 100% of patients who had been assigned to apply topical LUT014 had grade 0 or 1 radiation dermatitis as defined by Common Terminology Criteria for Adverse Events grading.


  1. Lutris Pharma receives FDA orphan drug designation for LUT014 for the treatment of EGFRI-induced acneiform rash. News release. PR Newswire. February 28, 2024. Accessed February 28, 2024. https://prnmedia.prnewswire.com/news-releases/lutris-pharma-receives-fda-orphan-drug-designation-for-lut014-for-the-treatment-of-egfri-induced-acneiform-rash-302073519.html
  2. Designating an orphan product: drugs and biological products. US Food and Drug Administration. Accessed February 28, 2024. https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
  3. Fabbrocini G, Panariello L, Caro G, Cacciapuoti S. Acneiform rash induced by EGFR inhibitors: review of the literature and new insights. Skin Appendage Disord. 2015 Mar;1(1):31-7. doi: 10.1159/000371821.
  4. Andrus E. Phase 1/2 data reveals positive effect of topical LUT014 for radiation-induced dermatitis in patients with breast cancer. Dermatology Times. February 21, 2024. Accessed February 28, 2024. https://www.dermatologytimes.com/view/phase-1-2-data-reveals-positive-effect-of-topical-lut014-for-radiation-induced-dermatitis-in-patients-with-breast-cancer
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