FDA Withdraws Krazati’s Colorectal Cancer Indication Following Confirmatory Trial Failure
On Sept. 1, 2026, the US Food and Drug Administration (FDA) finalized the voluntary withdrawal of Bristol Myers Squibb’s Krazati® (adagrasib) indication for the treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in the second-line setting. The indication had originally received FDA accelerated approval in 2024 based on response rate data from the phase I/II KRYSTAL-1 study. The withdrawal follows results from the phase III KRYSTAL-10 trial, which evaluated Krazati in combination with Erbitux® (cetuximab – Eli Lilly) versus chemotherapy in 461 previously treated patients. While the study demonstrated a favorable objective response rate, it failed to meet its co-primary endpoints of progression-free survival (PFS) and overall survival (OS), preventing confirmation of clinical benefit required under the accelerated approval pathway. Bristol Myers Squibb noted that its broader development strategy for Krazati remains focused on lung cancer, where pivotal studies are ongoing. Krazati’s FDA-approved indication for previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC) remains unchanged. The updated prescribing information can be found here.
Hyrnuo Gains First-Line FDA Approval for HER2-Mutant NSCLC
On Sept. 9, 2026, the FDA granted accelerated approval to Bayer’s Hyrnuo® (sevabertinib), an oral tyrosine kinase inhibitor (TKI) as a first-line treatment option for adults with locally advanced or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. This expands the drug’s original indication, granted in November 2025, for patients with the same mutation profile who had already received prior systemic therapy. Approval was based on treatment-naïve patients achieving a 75% objective response rate, including 6% complete and 70% partial responses, with 73% of responders sustaining a response for at least six months and 38% for at least a year. The recommended dose is 20mg (two tablets) taken orally twice daily with food until disease progression or unacceptable toxicity. Continued approval is contingent on verification of clinical benefit in the phase III SOHO-02 confirmatory trial versus standard of care. Here is the prescribing information.
FDA Approves Omcazio, a Food-Flexible Cabozantinib Formulation
The FDA granted final approval to Handa Oncology’s Omcazio™ (cabozantinib) capsules on Sept. 11, 2026, a lauryl sulfate salt formulation of cabozantinib. Unlike existing cabozantinib formulations, Omcazio is a novel alternate-salt formulation that demonstrated bioequivalence at lower doses and can be administered with or without food due to improved absorption and the absence of a clinically significant food effect. It was approved for the treatment of adult patients who have advanced renal cell carcinoma (RCC), advanced RCC in combination with Opdivo (nivolumab – BMS) as first-line therapy, hepatocellular carcinoma (HCC) previously treated with sorafenib, and adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced, or metastatic well-differentiated extra-pancreatic neuroendocrine tumors (epNET). It is available in capsule strengths designed to correspond to approved Cabometyx® (cabozantinib – Exelixis) dosing through FDA-approved conversion recommendations. The prescribing information includes a boxed warning regarding medication errors because Omcazio is not substitutable on a milligram-to-milligram basis with other cabozantinib products. Handa indicated that launch information will be available at a later date. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
2026-2027 Respiratory Season: Clinical Insights & Vaccine Updates Issues Document Now Available
As the 2026-2027 respiratory season begins, vaccination remains a primary strategy for reducing illness and hospitalizations from influenza, coronavirus disease 2019 (COVID-19) and respiratory syncytial virus (RSV). Key changes for this season include updated flu and COVID-19 vaccines, as well as continued use of RSV vaccines and monoclonal antibodies for vulnerable populations. This document summarizes trends, vaccine recommendations, available products, and pipeline developments affecting the 2026-2027 respiratory season.