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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Vivek Subbiah, MD, on Dabrafenib/Trametinib Efficacy in Biliary Tract Cancer

According to a recent study, led by Vivek Subbiah, MD, of The University of Texas MD Anderson Cancer Center, dabrafenib in combination with trametinib is an effective treatment option for patients with BRAFV600E -mutated biliary tract cancer (BTC). In an interview with i3 Health, Dr. Subbiah shares insights on the significance of these study results and unmet needs and future treatment in this patient population. What are the most challenging aspects of treating patients with BRAFV600E -mutated ...
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Dabrafenib/Trametinib Effective in Mutated Biliary Tract Cancer

Patients with biliary tract cancer often experience disease relapse after gemcitabine-based chemotherapy, representing an area of need in this patient population. In 5% of biliary tract tumors, a mutation in the BRAF gene is found. Dabrafenib in combination with trametinib has been shown to be an effective treatment option for patients with BRAFV600E – mutated cancers, particularly those with biliary tract cancer, according to a recent study, results of which were published in The Lancet Oncolog...
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Lurbinectedin Approved: Metastatic Small-Cell Lung Cancer

The FDA has granted accelerated approval to lurbinectedin (ZepzelcaTM, Pharma Mar, S.A.) for adults with metastatic small-cell lung cancer (SCLC) experiencing disease progression on or after platinum-based chemotherapy. The efficacy of lurbinectedin, a selective inhibitor of oncogenic transcription, was investigated in a multinational, single-arm, open-label phase 2 basket trial, PM1183-B-005-14 (Study B-005; NCT02454972), which enrolled adults with SCLC previously treated with only one chemothe...
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