FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

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

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

Verzenio delivers OS benefit in high-risk early breast cancer

Two years of adjuvant Verzenio (abemaciclib) plus endocrine therapy reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, according to the primary overall survival analysis of the phase III monarchE trial.

October 24, 2025

Vol.51 No.39

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

News Analysis Regulatory News

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.

October 17, 2025

Vol.51 No.38

By Claire Marie Porter and Jacquelyn Cobb

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

YOU MAY BE INTERESTED IN

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

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

Verzenio delivers OS benefit in high-risk early breast cancer

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Renew today!

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FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

YOU MAY BE INTERESTED IN

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

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

Verzenio delivers OS benefit in high-risk early breast cancer

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Never miss an issue!

Login

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough