FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Clinical Roundup

Zanzalintinib + atezolizumab improve survival in advanced CRC

Combining zanzalintinib, a targeted therapy drug, and atezolizumab, an immune checkpoint inhibitor, helped patients with metastatic colorectal cancer live longer and control their disease better than with the standard treatment drug regorafenib, according to a study led by UCLA investigators.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Trodelvy reduces risk of disease progression or death by 38% vs. chemo as first-line therapy in metastatic TNBC

Data from the phase III ASCENT-03 study demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival for Trodelvy (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Enhertu reduced the risk of disease recurrence or death vs. T-DM1 in high-risk HER2+ early breast cancer following neoadjuvant therapy

Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival in patients with a high risk of disease recurrence, according to results from DESTINY-Breast05 phase III trial.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Enhertu + THP before surgery resulted in a pathologic complete response in high-risk HER2+ early-stage breast cancer

Positive results from the DESTINY-Breast11 phase III trial showed Enhertu (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab, and pertuzumab in the neoadjuvant setting demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response rate.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Keytruda + Padcev reduced risk of EFS events and death for muscle-invasive bladder cancer when given before and after surgery

Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer who are not eligible for or declined cisplatin-based chemotherapy, according to phase III KEYNOTE-905/EV-303 trial data.

October 24, 2025

Vol.51 No.39

FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

YOU MAY BE INTERESTED IN

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Zanzalintinib + atezolizumab improve survival in advanced CRC

Trodelvy reduces risk of disease progression or death by 38% vs. chemo as first-line therapy in metastatic TNBC

Enhertu reduced the risk of disease recurrence or death vs. T-DM1 in high-risk HER2+ early breast cancer following neoadjuvant therapy

Enhertu + THP before surgery resulted in a pathologic complete response in high-risk HER2+ early-stage breast cancer

Keytruda + Padcev reduced risk of EFS events and death for muscle-invasive bladder cancer when given before and after surgery

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