FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.

Scientific advances have produced therapies that allow some people with metastatic breast cancer to live longer and better. We want that progress to continue, and we will continue to fight for the right research necessary to achieve it.

September 18, 2026

Vol.52 No.34

By Frances M. Visco and Michelle Tregear

Cancer Policy

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA announced the final design of the Expedited Investigational New Drug Pilot.

September 18, 2026

Vol.52 No.34

Clinical Roundup

AI may help identify breast cancers missed by mammograms, but clinical benefit remains uncertain, UCLA-led review finds

Artificial intelligence may help radiologists identify subtle signs of breast cancers that are missed during routine mammograms—and some AI systems may even identify patterns associated with an increased risk of cancer before it becomes visible on a mammogram—but there are still many significant limitations, according to a review led by investigators at the UCLA Health Jonsson Comprehensive Cancer Center.

September 18, 2026

Vol.52 No.34

Clinical Roundup

Personalized weight-loss care benefits breast cancer survivors, JHU-led study finds

A personalized approach to obesity treatment may help breast cancer survivors improve their long-term health by identifying early which patients need more than behavioral lifestyle intervention alone, according to a Johns Hopkins Kimmel Cancer Center-led clinical trial.

September 18, 2026

Vol.52 No.34

Drugs & Targets

FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

September 18, 2026

Vol.52 No.34

Drugs & Targets

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

FDA has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

September 18, 2026

Vol.52 No.34

FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

YOU MAY BE INTERESTED IN

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

AI may help identify breast cancers missed by mammograms, but clinical benefit remains uncertain, UCLA-led review finds

Personalized weight-loss care benefits breast cancer survivors, JHU-led study finds

FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

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FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

YOU MAY BE INTERESTED IN

Scientific progress can’t help people if they can’t access careThis is a policy problem. And it is one we can change.

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

AI may help identify breast cancers missed by mammograms, but clinical benefit remains uncertain, UCLA-led review finds

Personalized weight-loss care benefits breast cancer survivors, JHU-led study finds

FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

Never miss an issue!

Login

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.