FDA accepts supplemental BLAs for two Opdivo regimens

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

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

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

FDA accepts supplemental BLAs for two Opdivo regimens

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

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

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

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