Biomarker-driven innovation: What the FDA’s evolving strategy means for oncology

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

Drugs & Targets

FDA grants accelerated approval to iberdomide combination for MM

FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

September 11, 2026

Vol.52 No.33

Drugs & Targets

FDA grants accelerated approval to camizestrant combination for HR+ metastatic breast cancer

FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.

September 11, 2026

Vol.52 No.33

Drugs & Targets

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

FDA 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 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

September 11, 2026

Vol.52 No.33

Drugs & Targets

FDA approves first-of-its-kind drug rusfertide for polycythemia vera

FDA approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.

September 11, 2026

Vol.52 No.33

Podcast

Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

In last week’s issue of The Cancer Letter, Raja Flores wrote a guest editorial explaining how he, with his expertise in thoracic surgery, took issue with a nuance in a recent Keytruda commercial.

August 19, 2026

Biomarker-driven innovation: What the FDA’s evolving strategy means for oncology

YOU MAY BE INTERESTED IN

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

FDA grants accelerated approval to iberdomide combination for MM

FDA grants accelerated approval to camizestrant combination for HR+ metastatic breast cancer

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

FDA approves first-of-its-kind drug rusfertide for polycythemia vera

Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

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