European Commission Approves Adagrasib for KRAS G12C-Mutated NSCLC
On January 10, the European Commission granted conditional marketing authorization for adagrasib as a targeted treatment option for adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one previous systemic therapy.
Adagrasib demonstrated a positive benefit-risk profile based on Phase 2 data from the KRYSTAL-1 study. KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.
“Adagrasib offers an efficacious and tolerable therapeutic option for patients living with advanced KRAS G12C-mutated NSCLC and this approval expands the potential treatment options available,” Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany, said in a press release. “With its differentiated profile, adagrasib offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in tailoring treatment approaches for patients.”
The conditional marketing authorization for adagrasib is valid in all 27 European Union member states plus Iceland, Norway, and Liechtenstein. Previously, the US Food and Drug Administration granted accelerated approval of adagrasib in December 2022 based on 1-year KRYSTAL-1 data. Two-year follow-up data from the trial were presented at the 2023 World Conference on Lung Cancer in September.
US FDA Accepts Premarket Approval Application for Tumor Treating Fields Therapy
On January 19, the US Food and Drug Administration accepted an application for premarket approval for tumor treating fields therapy (TT fields) by Switzerland-based Novocure. The company is seeking approval of TT fields therapy with standard systemic therapies for the treatment of NSCLC following progression on or after platinum-based therapy.
The application is supported by data from the LUNAR study, which tested the safety and efficacy of TT fields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Data from the LUNAR study were presented at the 2023 American Society of Clinical Oncology meeting.
The application is now under review by the FDA, and a regulatory decision from the FDA is expected in the second half of 2024.
