The US FDA has approved Priovant Therapeutics’ Lisraya (brepocitinib) tablets, the first FDA-approved oral treatment option for patients with dermatomyositis.

Dermatomyositis is a rare autoimmune disease in which the immune system attacks the muscles and skin, causing chronic inflammation, progressive muscle weakness and distinctive skin rashes. By blocking JAK pathways, which play a key role in the body’s immune and inflammatory responses, Lisraya helps reduce the harmful inflammation that damages the muscles and skin, offering an effective new option for disease control.

The efficacy and safety of Lisraya were evaluated in a phase 3 study that included 241 adults randomised to receive Lisraya 30mg once daily, brepocitinib 15mg once daily or placebo for a 52-week treatment period.

The study used a standardised scoring tool that tracks changes across six areas (muscle strength, physical function, skin and other disease activity, muscle enzymes, and both physician and patient assessments of overall health) to assess how much a patient’s dermatomyositis has improved. Participants showed improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week 48.

MSD (known as Merck & Co in the US and Canada) and Moderna have announced positive topline results from the phase 3 INTerpath-001 trial evaluating intismeran autogene, in combination with Keytruda (pembrolizumab), to treat patients with completely resected stage IIB-IV melanoma.

Intismeran autogene is an mRNA-based individualised neoantigen therapy (INT) designed specifically for individual patients based on the unique set of mutations within their tumours to train and activate the immune system to recognise and fight cancer.

This is the first and only combination regimen to demonstrate statistically significant and clinically meaningful improvements in recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared to Keytruda alone for patients with resected melanoma.

Melanoma, one of the deadliest forms of skin cancer, is characterised by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the US, skin cancer is one of the most common types of cancer diagnosed and melanoma accounts for a large majority of skin cancer deaths.