FDA grants Fast Track designation for Reqorsa with Keytruda in NSCLC

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

Zipalertinib + chemo meets primary endpoint in phase III REZILIENT3 trial in first-line EGFR exon 20 insertion mutation NSCLC

The REZILIENT3 trial, a global phase III clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations, met its primary endpoint of progression-free survival at a planned interim analysis.

September 11, 2026

Vol.52 No.33

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

FDA grants Fast Track designation for Reqorsa with Keytruda in NSCLC

YOU MAY BE INTERESTED IN

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

Zipalertinib + chemo meets primary endpoint in phase III REZILIENT3 trial in first-line EGFR exon 20 insertion mutation NSCLC

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

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