Personalis Real-Time Variant Tracker identifies resistance mutations across several hundred clinically relevant hotspots

Oncology has a semantics problem: How do we define “early stage”?

I recently found myself asking a question that I thought had an obvious answer: What is early-stage cancer?

October 09, 2026

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

FDA approved Tuksya (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tuksya to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

October 09, 2026

Vol.52 No.37

Regulatory News

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.

October 02, 2026

Vol.52 No.36

By Claire Marie Porter

Drugs & Targets

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

FDA accepted the company’s supplemental New Drug Application and granted Priority Review designation for Lynkuet (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer.

October 02, 2026

Vol.52 No.36

How biology is reshaping breast cancer care

Breast cancer treatment has changed dramatically over the past decade. One of the most important advances has been our growing ability to understand the biology of each patient’s cancer and use those insights to guide treatment decisions more precisely. That shift is helping make personalized cancer care a reality.

36 months to live, 29 months to wait. Why is Congress withholding lifesaving benefits from breast cancer patients?

In this episode of The Cancer Letter Podcast, Fran Visco, president of the National Breast Cancer Coalition, and Jacquelyn Cobb, managing editor of The Cancer Letter, discuss the Metastatic Breast Cancer Act, bipartisan legislation that would eliminate the waiting periods for Social Security Disability Insurance and Medicare for eligible people with metastatic breast cancer.

September 23, 2026

Personalis Real-Time Variant Tracker identifies resistance mutations across several hundred clinically relevant hotspots

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Oncology has a semantics problem: How do we define “early stage”?

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

How biology is reshaping breast cancer care

36 months to live, 29 months to wait. Why is Congress withholding lifesaving benefits from breast cancer patients?

Renew today!

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Personalis Real-Time Variant Tracker identifies resistance mutations across several hundred clinically relevant hotspots

YOU MAY BE INTERESTED IN

Oncology has a semantics problem: How do we define “early stage”?

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

How biology is reshaping breast cancer care

36 months to live, 29 months to wait. Why is Congress withholding lifesaving benefits from breast cancer patients?

Never miss an issue!

Login

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?