Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

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

City of Hope blood test shows promise for detecting pancreatic cancer at its earliest stages

Researchers at City of Hopeled the development of a new, investigational blood test that could detect pancreatic cancer at its earliest stages, when the disease is more treatable and potentially curable.

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

Cancer Policy

Heidi Overton selected as FDA commissioner; Jared Seehafer named inaugural Deputy Commissioner for Technology and AI

As part of a sweep of leadership changes at FDA, Heidi Overton, deputy director of the White House Domestic Policy Council, has been nominated to the role of FDA commissioner.

September 11, 2026

Vol.52 No.33

By Claire Marie Porter

Clinical Roundup

Botensilimab + balstilimab showed no CRC recurrences in resectable colon cancer, phase II NEST trial shows

The phase II NEST trial evaluating neoadjuvant botensilimab, a multifunctional, Fc-enhanced anti-CTLA-4 antibody, and balstilimab, an anti-PD-1 antibody, showed no colorectal cancer recurrences in patients with resectable colon cancer.

September 11, 2026

Vol.52 No.33

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

YOU MAY BE INTERESTED IN

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

City of Hope blood test shows promise for detecting pancreatic cancer at its earliest stages

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

Heidi Overton selected as FDA commissioner; Jared Seehafer named inaugural Deputy Commissioner for Technology and AI

Botensilimab + balstilimab showed no CRC recurrences in resectable colon cancer, phase II NEST trial shows

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