Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon

While every agency under HHS, particularly FDA, has seen historic leadership shakeups and massive cuts to personnel and funding over the course of the second Trump administration—NCI has been spared, even getting a small raise, under the direction of NCI Director Anthony Letai.

May 27, 2026

Cancer Policy

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

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

FDA approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) immunotherapy in muscle-invasive bladder cancer.

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

Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

YOU MAY BE INTERESTED IN

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon

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

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

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

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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