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 An updated draft guidance document from FDA regarding this pathway and some compelling data regarding the public's perceived value of newly approved drugs for cancer.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!

A first-in-class approval of a bispecific HER2-HER3 monoclonal antibody for NRG1 fusion (+) NSCLC and pancreatic cancer.

The 1st menin inhibitor, revumenib, is approved for relapsed/refractory acute leukemias.

Understanding the Pathway: https://doi.org/10.1200/JCO-24-01265

A nice editorial succinctly summarizes a framework for thinking about how to incorporate anthracyclines into the treatment of early stage breast cancer patients.

Anthracyclines in Early Breast Cancer: The Long Goodbye -https://doi.org/10.1200/JCO-24-01916

10-year Outcomes of READ trial: https://doi.org/10.1200/JCO.24.00836

Bonus - Practical Guide for Testing for Pharmacogenomics: https://doi.org/10.1200/OP.24.00191

Reviewing the data to support use of dexamethasone solution mouthwash for PIK3/AKT/mTOR inhibitor-induced stomatitis, caused by drugs like everolimus, alpelisib, capivasertib, & inavolisib.

SWISH: https://doi.org/10.1016/s1470-2045(17)30109-2

Alliance MIST Trial: https://doi.org/10.1053/j.seminoncol.2023.01.001

The first Cldn 18.2 targeting monoclonal antibody has been improved. Let's talk about it!

Discussing two excellent articles from earlier this month.

S1826: N-AVD vs. Bv-AVD (DOI: 10.1056/NEJMoa2405888)

&

INTERLACE: induction chemo prior to concurrent cisplatin/RT in locally advanced cervical cancer (DOI: https://doi.org/10.1016/S0140-6736(24)01438-7)