Martha Donoghue named FDA OCE associate director for pediatric oncology and rare cancers

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

April 12, 2024

Vol.50 No.15

White House

White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups

A coalition of health and physician groups earlier this week filed a lawsuit seeking to force FDA to finalize a long-delayed final rule banning menthol cigarettes.

FDA approves Abecma for earlier lines of treatment for MM

FDA approved Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial (The Cancer Letter, March 22, 2024).

April 05, 2024

Vol.50 No.14

Regulatory News

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

FDA issued Complete Response Letters for the Biologics License Application for odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma, each after two or more lines of systemic therapy.

UF Health Proton Therapy Institute adds interactive video wall for pediatric patients

The UF Health Proton Therapy Institute enhanced its playroom, a respite for its pediatric patients, significantly with innovative technology that promotes therapeutic engagement, with an 86” interactive gaming wall that features educational and sensory software.

March 29, 2024

Vol.50 No.13

Clinical Roundup

USC researchers find genetic variant contributing to disparities in childhood leukemia risk

Researchers from the University of Southern California found a genetic variant contributing to disparities in childhood leukemia risk. The variant, located on the IKZF1 gene, helps explain why Hispanic/Latino children face a higher risk of acute lymphoblastic leukemia and offers insights about what causes the disease.

March 29, 2024

Vol.50 No.13

Martha Donoghue named FDA OCE associate director for pediatric oncology and rare cancers

YOU MAY BE INTERESTED IN

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups

FDA approves Abecma for earlier lines of treatment for MM

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

UF Health Proton Therapy Institute adds interactive video wall for pediatric patients

USC researchers find genetic variant contributing to disparities in childhood leukemia risk

Renew today!

Subscriber content

Login