Lots of FDA approval updates to discuss from the past few weeks:

-Zongertinib gets approved in 1st line setting for ERBB2 TKD mutated metastatic NSLCLC

-Encorafenib approval with cetuximab + FOLFOX

-Teclistamab + Daratumumab approved in 2nd line setting for r/r multiple myeloma

-Acalabrutinib + venetoclax (but NOT acalabrutinib + venetoclax + obinutuzumab) is approved for CLL

Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

This week discuss BR.31 trial of adjuvant durvalumab in NSCLC and put it into the context of the positive studies with atezolizumab and pembrolizumab. We also highlight 2 notable presentations at ASCO GU 2026 on perioperative enfortumab vedotin + pembrolizumab in cisplatin-eligible patients with resectable bladder cancer (KEYNOTE-B15) and advjuant pembrolizumab + belzutifan in RCC (LITESPARK-022)

Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

An exciting new drug, rezatapopt, may be effective in restoring p53 activity in cancers - a possible major therapeutic breakthrough. Can colchicine treat pyrexia from tremetinib & dabrafenib use? This case series says - maybe: https://doi.org/10.1007/s00520-019-4654-2

Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

The EV-303 trial that led to the FDA approval of perioperative enfortumab vedotin + pembrolizumab in cisplatin-ineligible bladder cancer patients in now published in NEJM. We discuss the results and ponder potential future changes to treating bladder cancer in the future.

Urinary diversion surgeries: https://jamanetwork.com/journals/jamaoncology/fullarticle/2842595

We have FDA changes to the labels of Axi-Cel (to allow for its use in primary CNS lymphoma) and 5-flourouracil (pre-treatment DPYD testing).

Also, pembrolizumab nets another approval, this time in conjunction with paclitaxel for platinum-resistant ovarian cancer (limited to PD-L1 CPS of 1% of greater)

A brief discussion of the Core Communication Skills* and how to incorporate them into a chemotherapy education session.

*Rapport Building

*Agenda Setting

*Information Management

*Active Listening

*Addressing Feelings

*Common Ground

Reviewing the hot-off-the press publication of PATINA, palbociclib in HER-2 amplified breast cancer along with endocrine therapy and HER-2 targeted antibodies.

We review the recent ASCENT-04/Keynote-D19 publication of sacituzuab govitecan + pembrolizumab for PD-L1 CPS of 10% and above TNBC compared to chemo + pembrolizumab alone.

Also, a quick recap of ASCO GI earlier this month with mentions of zanidatamab and zolbetuximab.

Finally, a check-in on The Pitt.

This episode is the 2nd chapter in a broader presentation about putting together the puzzle pieces of oncology drug use. This chapter discusses examples of how oncology drug use changes over time.

Video & slides available at: https://youtu.be/Kxs0Xg9Ug_c?si=yOwEU1X-7mCPoQl5

A Holiday tradition like few other. Are we keeping, regifting, or returning new oncology drugs approved in 2025?