FDA grants Fast Track designation for Reqorsa with Keytruda in NSCLC

Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

Non-classical mutations are present in 20-30% of all patients with epidermal growth factor receptor-mutated non-small cell lung cancer, according to an analysis of real-world evidence presented by Black Diamond Therapeutics, Inc. at the American Association of Cancer Research annual meeting.

April 12, 2024

Vol.50 No.15

Drugs & Targets

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.

Observational study demonstrates clinical validity and utility of OncoHost’s PROphet NSCLC test

A mutli-center observational study demonstrated the clinical validity and utility of the PROphet non-small cell lung cancer test, a plasma proteome machine learning-based decision-support tool designed to identify patient subsets benefiting from PD-1/PD-L1 inhibitor-based therapies.

March 29, 2024

Vol.50 No.13

FDA grants Fast Track designation for Reqorsa with Keytruda in NSCLC

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Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

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

Observational study demonstrates clinical validity and utility of OncoHost’s PROphet NSCLC test

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