The Targeted Pulse: Key Approvals, Regulatory Shifts, and ASCO Highlights

This week, the oncology landscape buzzed with significant updates, from crucial FDA decisions to groundbreaking data emerging from the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Here's a quick recap of the top stories that captivated our readers:

FDA Greenlights Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

The FDA has expanded the approval of darolutamide (Nubeqa). This important decision offers a new treatment option, either as a standalone therapy or in combination with docetaxel, for patients battling metastatic castration-sensitive prostate cancer. Read more about this approval here.

Regulatory Shift: Patritumab Deruxtecan BLA Withdrawn in EGFR+ NSCLC

In a notable regulatory development, the biologics license application for patritumab deruxtecan in EGFR-positive non–small cell lung cancer (NSCLC) has been withdrawn. This move, following discussions with the FDA, marks a significant update for the EGFR-positive NSCLC community. Find out more.

ASCO 2025 Buzz

The 2025 ASCO Annual Meeting continues to deliver impactful research, and several presentations caught our readers' attention:

• Atezolizumab/Cabozantinib Shows Promise in Second-Line RCC: Data presented at ASCO revealed that the combination of atezolizumab (Tecentriq) and cabozantinib, or cabozantinib (Cabometyx) alone, demonstrated efficacy and a manageable safety profile in patients with second-line renal cell carcinoma. Dive into the details here.
• Neoadjuvant PAXG Excels in Pancreatic Cancer: A significant finding for pancreatic ductal adenocarcinoma (PDAC) emerged, showing that neoadjuvant PAXG (cisplatin, nab-paclitaxel, gemcitabine, and capecitabine) substantially improved event-free survival compared with modified FOLFIRINOX in resectable and borderline resectable cases. Learn more about this breakthrough here.
• Atezolizumab/Chemo Halves Recurrence Risk in dMMR Colon Cancer: Atezolizumab combined with standard chemotherapy significantly reduced the risk of recurrence or death by 50% compared with chemotherapy alone in patients with Stage III colon cancer with deficient mismatch repair and chemotherapy resistance. Learn more.

Stay tuned as we continue to bring you the latest and most impactful news in oncology!