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FDA issues warning for CDK 4/6 inhibitors
In a review of trials and postmarket safety databases, the FDA found there were reports of serious cases of pneumonitis, including fatalities,...
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FDA approves darolutamide for nonmetastatic CRPC
The approval was based on improved metastasis free survival in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-...
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FDA approves bevacizumab-bvzr for several cancers
The bevacizumab biosimilar is now approved for metastatic colorectal cancer, advanced non-squamous non–small cell lung cancer, recurrent...
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FDA approves pembrolizumab for advanced SCLC
The approval was based on an overall response rate of 19% in two nonrandomized trials.
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FDA approves trastuzumab-anns for HER2-positive breast, gastric cancer
This is the fifth FDA approval of a trastuzumab biosimilar.
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FDA approves NovoTTF-100L System for advanced mesothelioma
The System delivers electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division and can be prescribed only by a...
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FDA approves T-DM1 as adjuvant treatment
The antibody-drug conjugate is approved for patients with HER2-positive early breast cancer who have residual invasive disease following...
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FDA approves pembrolizumab for first-line stage III NSCLC
Approval was based on improved overall survival for patients taking pembrolizumab, compared with those taking the investigators’ choice of...
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FDA approves palbociclib for men with HR+/HER2- advanced breast cancer
The FDA advises health care providers to tell male patients with female partners of reproductive potential to use effective contraception during...
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FDA approves cabozantinib for previously treated HCC
Approval was based on improvement in overall survival versus placebo in the phase 3 CELESTIAL trial.
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BMI changes in adolescence linked to later cancer risk
Adiposity changes during the peripubertal period may have more of an impact on ovarian cancer risk than adiposity changes during adulthood.
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FDA approves Elzonris for blastic plasmacytoid dendritic cell neoplasm
This is the first approved therapy for BPDCN, an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, and can...
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FDA approves olaparib for maintenance treatment of BRCA-mutated advanced ovarian cancer
The FDA also approved a companion diagnostic, the BRACAnalysis CDx test, to identify patients with gBRCAm advanced epithelial ovarian, fallopian...
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FDA approves Nplate for pediatric ITP
Approval is for pediatric patients who’ve had ITP for at least 6 months but had no good response to corticosteroids, immunoglobulins, or...
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Atezolizumab combination regimen approved for advanced non-squamous NSCLC
The FDA approved checkpoint inhibitor atezolizumab for the treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor...