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

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

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

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

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

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

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 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

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!

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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