The FDA granted accelerated approval to olaparib (Lynparza) as adjuvant treatment for adults with germline BRCA1- or BRCA2-mutated, HER2-negative, high-risk early breast cancer following (neo)adjuvant chemotherapy, based on the randomized, double-blind, placebo-controlled, phase 3 OlympiA trial (ClinicalTrials.gov NCT02032823). The original primary analysis (DOI 10.1056/NEJMoa2105215) reported a significant invasive disease-free-survival benefit; a subsequent overall-survival analysis (DOI 10.1016/j.annonc.2022.09.159) reported significantly longer overall survival as well. A later, more mature follow-up — presented at the 2024 San Antonio Breast Cancer Symposium at a median follow-up of roughly six years — reportedly continued to show both invasive-disease-free-survival and overall-survival benefit for olaparib versus placebo; this six-year figure comes from a conference presentation that has not yet been confirmed as published in a distinct peer-reviewed paper, so it is treated with conference-abstract-level caution even though the underlying, already-FDA-approved indication itself rests on the two published papers above.

The FDA approved sotorasib (Lumakras) in combination with panitumumab (Vectibix) for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior fluoropyrimidin-, oxaliplatin-, and irinotecan-based chemotherapy — the first FDA-approved KRAS G12C-targeted combination for this cancer type, and a biomarker-selected, precision-medicine approach that requires confirming the specific KRAS G12C mutation before treatment. The approval was based on the randomized, open-label, phase 3 CodeBreaK 300 trial (ClinicalTrials.gov NCT05198934; a 3-year overall-survival update presented at ASCO 2024, Journal of Clinical Oncology, DOI 10.1200/JCO.2024.42.17_suppl.LBA3510). In the analysis population supporting approval, sotorasib (960 mg daily) plus panitumumab (53 patients) achieved a median progression-free survival of 5.6 months versus 2.0 months with standard-of-care chemotherapy (54 patients; hazard ratio 0.48), and an objective response rate of 26% versus 0%.