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

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

Podcast

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

In last week’s issue of The Cancer Letter, the cover story featured something special: The first de novo book published by The Cancer History Project. The book, “Backwater to Blockbuster: St. Jude Children’s Research Hospital,” co-written by Charles J. Sherr and William E. Evans, chronicles the previously untold story of St. Jude Children’s Research Hospital and its rise to becoming a global leader in pediatric cancer research.

May 20, 2026

Clinical

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

In a recent set of regulatory decisions that culminated in the resignation of FDA Commissioner Marty Makary on May 12, the agency appears to have reversed its hard-ball stance on flavored e-cigarettes.

May 15, 2026

Vol.52 No.19

By Sara Willa Ernst

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

YOU MAY BE INTERESTED IN

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

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

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

YOU MAY BE INTERESTED IN

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

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applicationsCritics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

Never miss an issue!

Login

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market