Prostate Cancer: CHIP Interferes With PARP Inhibitor Eligibility Testing

In a case series study in advanced prostate cancer, 10% of patients were shown to have clonal hematopoiesis of indeterminate potential (CHIP) variants in genes used to determine eligibility for poly(ADP)-ribose polymerase (PARP) inhibitor therapy, making it essential that circulating free DNA (cfDNA) testing include a paired whole-blood control to exclude CHIP variants and avoid misdiagnosis. "There is an urgent need to better understand this problem following recent US Food and Drug Admini...
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Final Overall Survival Results: Olaparib for Metastatic Castration-Resistant Prostate Cancer

Olaparib prolongs overall survival compared with enzalutamide or abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) and gene alterations in BRCA1, BRCA2, or ATM, according to the final survival analysis of the phase 3 PROfound trial. These results were presented yesterday at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and simultaneously published in the New England Journal of Medicine. "Metastatic castration-resistant prostate cancer r...
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Pralsetinib Approved: RET Fusion-Positive Non-Small Cell Lung Cancer

The FDA has granted accelerated approval to pralsetinib (GavretoTM, Blueprint Medicines Corporation), an oral selective RET kinase inhibitor, for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by the OncomineTM Dx Target (ODxT) Test (Life Technologies Corporation), which has also been approved as a companion diagnostic. RET alterations are implicated in 1% to 2% of NSCLC cases, as well as in a number of other cancer types. The pralsetin...
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Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...
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Pyrotinib/Capecitabine Effective for HER2-Positive Metastatic Breast Cancer

Pyrotinib, an irreversible pan-ErbB inhibitor, provides an effective treatment option in combination with capecitabine for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, according to results of a phase 3 trial to be presented later this month in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The open-label, multicenter PHOEBE trial enrolled patients with HER2-positive metastatic breast cancer following treatment...
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