FDA Approvals Roundup: Kimmtrak, Skyrizi, Veklury
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approval
Kimmtrak okayed for advanced uveal melanoma
Immunocore’s Kimmtrak (tebentafusp-tebn; injection) has been approved for treating unresectable or metastatic uveal melanoma (mUM) in adults who are HLA-A*02:01 positive and have not received previous treatment. It is the first drug approved for this condition.
The approval was based on findings from the Phase 3 IMCgp100-202 clinical trial in which 378 patients from the indicated population were randomized 2:1 to receive Kimmtrak or an investigator’s choice of pembrolizumab, ipilimumab, or dacarbazine (control group). At 1 year, overall survival was 73% in the Kimmtrak group and 59% in controls in the intention-to-treat population. Progression-free survival at 6 months was 31% and 19%, respectively.
Kimmtrak was granted breakthrough therapy designation for the approved indication. The company used the assessment aid, and the application was reviewed under the Real-Time Oncology Review program and Project Orbis (in collaboration with the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency, Health Canada, and the Australian Therapeutic Goods Administration).
The therapy comes with a boxed warning for cytokine release syndrome.
New indications
Skyrizi use extended for active psoriatic arthritis in adults
AbbVie’s Skyrizi (risankizumab-rzaa; injection) has been granted a new indication for treating adults with active psoriatic arthritis (PsA).
Approval of the expanded indication was supported by findings from two Phase 3, randomized, double-blind, placebo-controlled studies in 1,407 patients from the indicated population: the KEEPsAKE 1 study, with patients who had an inadequate response or intolerance to at least one disease-modifying antirheumatic drugs (DMARD); and KEEPsAKE 2, in those with an inadequate response or intolerance to biologic therapy and/or DMARDs. They were randomized to receive Skyrizi or placebo. By week 24, patients in both studies who were receiving Skyrizi showed improvement from baseline on the ACR20 measure of change in symptoms. Skyrizi patients in both studies also showed statistically significant improvement from baseline in physical function, compared with placebo. The studies are ongoing.
Skyrizi, an interleukin-23 antagonist, was originally approved in 2019 for treating moderate-to-severe plaque psoriasis in adults.
Veklury nabs new indication for mild COVID-19 in adult and pediatric outpatients
Gilead’s Veklury (remdesivir; injection) has received been granted a new indication for treating mild to moderate COVID-19 in certain non-hospitalized adults and pediatric patients. Veklury was originally approved in 2020 to treat patients with COVID-19 who required hospitalization.
The agency also revised the emergency use authorization for Veklury for pediatric patients younger than 12 years who are not hospitalized and have mild-to-moderate COVID-19.
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.