AstraZeneca

The FDA granted breakthrough therapy designation to Daiichi Sankyo's ADC datopotamab deruxtecan for EGFR-mutated NSCLC, based on early TROPION-Lung05 trial results showing clinically meaningful tumor response. The drug, co-developed with AstraZeneca, aims to address significant unmet needs in advanced NSCLC treatment.

The FDA granted Breakthrough Therapy Designation to AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) for EGFR-mutated NSCLC patients who progressed after EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 and TROPION-Lung01 trials. Lung cancer is the leading cause of cancer deaths in the US, with NSCLC accounting for 80-85% of cases.

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Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation (BTD) in the US for treating EGFRm NSCLC patients progressing after EGFR-TKI and platinum-based chemotherapy. Developed by Daiichi Sankyo and AstraZeneca, the BTD was based on TROPION-Lung05 and TROPION-Lung01 trial data. AstraZeneca and Daiichi Sankyo also submitted a Biologics License Application for accelerated approval.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but with stricter controls. Biosimilars, including Humira’s, have struggled with adoption despite cost savings potential. Optum Rx also adds and removes various oncology and CNS medications for 2025.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but is subject to prior authorization. Biosimilars have struggled with low adoption despite cost advantages, but large PBMs like CVS Health are shifting towards biosimilars. Optum Rx also adds and removes various oncology and CNS medications from its 2025 formulary.

The FDA granted breakthrough therapy designation to datopotamab deruxtecan for EGFR-mutated NSCLC progressing after EGFR TKI and platinum-based chemotherapy. Data from TROPION-Lung05 and TROPION-Lung01 trials showed an ORR of 42.7%, DCR of 86.3%, and median OS of 15.6 months. AstraZeneca and Daiichi Sankyo submitted a BLA for accelerated approval in November 2024.

Acalabrutinib plus venetoclax, with or without obinutuzumab, improved PFS over standard-of-care chemoimmunotherapy in treatment-naive CLL patients, reducing progression risk by 35% and 58%, respectively.