FDA approves Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer

FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

In further major FDA shake-ups, three top regulators left the agency on May 15, just days after the resignation of Commissioner Marty Makary.

May 22, 2026

Vol.52 No.20

By Claire Marie Porter

Clinical Roundup

Imfinzi regimen reduced early disease recurrence in non-muscle-invasive bladder cancer, phase III trial POTOMAC shows

Exploratory analyses of the POTOMAC phase III trial showed adding one year of treatment with AstraZeneca’s Imfinzi (durvalumab) to BCG induction and maintenance therapy reduced the number of high-risk disease recurrences within the first year, with fewer BCG-unresponsive recurrences in patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer compared to BCG treatment alone.

May 22, 2026

Vol.52 No.20

Clinical Roundup

Perioperative Imfinzi + neoadjuvant EV improved EFS and OS in muscle-invasive bladder cancer, phase III VOLGA trial shows

High-level results from a planned interim analysis of the VOLGA phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with muscle-invasive bladder cancer versus standard of care.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA grants orphan drug designation for CLN-049 in r/r AML

FDA granted orphan drug designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia .

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.

May 22, 2026

Vol.52 No.20

FDA approves Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

Imfinzi regimen reduced early disease recurrence in non-muscle-invasive bladder cancer, phase III trial POTOMAC shows

Perioperative Imfinzi + neoadjuvant EV improved EFS and OS in muscle-invasive bladder cancer, phase III VOLGA trial shows

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA grants orphan drug designation for CLN-049 in r/r AML

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

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