We take a deep look at the recently published, and guideline changing, AMPLIFY trial of fixed-duration acalabrutinib in CLL.

Link: DOI: 10.1056/NEJMoa2409804

Morbidity & Mortality (M & M) are common case conferences to learn from unfortunate cases to improve care in the future. This episode looks at two recently published case reports.

1. Fatal tumor lysis syndrome following a lack of venetoclax ramp-up in AML: https://www.jhoponline.com/issue-archive/2024-issues/december-2024-vol-14-no-6/rapid-onset-of-fatal-tumor-lysis-syndrome-in-a-patient-with-acute-myeloid-leukemia-receiving-azacitidine-and-venetoclax-without-a-ramp-up-schedule-a-case-report

2. CD4+ T-cell lymphoma harboring a CAR integration into TP53: https://www.nejm.org/doi/full/10.1056/NEJMoa2411507

Dipping into the archives (technology issues with new computer) to re-release the Foundations of OncoPharm episode on rituximab. Where did that 375 mg/m2 dose come from anyway?

FDA approves two new treatment regimens:

1. Acalabrutinib + BR for untreated mantle cell lymphoma patients deemed ineligible for autologous HSCT

2. Sotorasib + panitumumab for KRAS-G12C mutated metastatic colorectal cancer (after chemotherapy, including oxaliplatin and irinotecan)

Datopotamab deruxtecan, a newly approved agent for breast cancer, is discussed.

HOPA Pharmacy Outcomes & Practice-Based Collaboration Survey: https://www.surveymonkey.com/r/MXNVRBR

Dexamethasone Dosing Intensity in Multiple Myeloma: https://doi.org/10.1182/blood.2024025939

Talquetamab + Teclistamab: https://doi.org/10.1182/blood.2024025939

postMONARCH: https://doi.org/10.1200/JCO-24-02086

We discuss recent approvals of ensartinib and nivolumab-hyaluronidase as well as new front-line option for BRAV-V600E mutated metastatic colorectal cancer.

Weighing the Pros & Cons of the accelerated approval pathway as it relates to oncology. An updated draft guidance document from FDA regarding this pathway and some compelling data regarding the public's perceived value of newly approved drugs for cancer.

Article: Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment. Forest R, et al. Lancet Oncology 2024. Link: https://doi.org/10.1016/S1470-2045(24)00596-5

Looking back at new approvals from 2024 - what to keep, re-gift, or return?

And yes, as soon as this was recorded 2 new drugs were approved.

Lots of recent clinical trial updates to discuss:

AQUILA: Daratumumab for high-risk smoldering multiple myeloma

Checkmate 8HW: Nivo/Ipi for MSI-high/MMRd metastatic colorectal cancer

DESTINY-Breast06: T-DXd in HER2-low MBC after hormonal treatment, but without previous chemo for MBC

ARMANI: Switch maintenance ramucirumab-paclitaxel in metastatic gastric/GEJ cancer

HELEN-006: Neoadjuvant nab-paclitaxel/trastuzumab/pertuzumab vs. TCHP in breast cancer

SONIA: finally published!