Fedratinib Approved for Myelofibrosis

​ The FDA has now approved fedratinib (Inrebic®, Impact Biomedicines, Inc./Celgene Corporation) for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis. A myeloproliferative neoplasm, myelofibrosis can either present as a primary condition or as a secondary condition following the transformation of polycythemia vera or essential thrombocythemia. Myelofibrosis causes anemia, splenomegaly, and debilitating symptoms, and it shortens survival. "Prior to today, there was o...
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Entrectinib: FDA Approved for NTRK-Fusion Positive Cancer

Entrectinib (Rozlytrek™, Genentech, Inc.) has just been FDA approved for use as treatment for patients with cancers containing neurotrophic tyrosine receptor kinase (NTRK) gene fusion, which is a genetic defect. This drug is to be used if there are no other effective treatments available. This approval marks the third time the FDA has approved a cancer drug based on a biomarker instead of tumor type. These types of approvals are beginning a paradigm in the development of cancer treatments for "t...
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Pembrolizumab for Advanced Esophageal Squamous Cell Carcinoma: An Interview with Ken Kato, MD

On July 30, 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) whose tumors expressed a programmed death-ligand 1 (PD-L1) combined positive score (CPS) of at least 10 and whose disease progressed after at least one line of systemic therapy. The approval was based on two clinical trials. One of these was Keynote-181, which enrolled 628 patients with locally advanced or metastatic ESCC w...
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Pexidartinib: First Approval for Tenosynovial Giant Cell Tumor

The FDA has now approved pexidartinib (Turalio TM , Daiichi Sankyo, Inc.) for adults with symptomatic tenosynovial giant cell tumor (TGCT) that does not respond to surgery and is associated with severe morbidity or functional limitations. This is the first FDA approval for TGCT. A locally aggressive neoplasm of the synovium of joints and tendon sheaths, TGCT is a rare disease that causes inflammation, pain, swelling, and the destruction of joints. Symptoms result in part from colony-stimulating ...
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Pembrolizumab Approved for Advanced Esophageal Squamous Cell Carcinoma

Pembrolizumab (Keytruda®, Merck) has been approved by the FDA for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) with tumors expressing a programmed death ligand-1 (PD-L1) combined positive score (CPS) of at least 10 and with disease progression following one or more previous systemic treatments. The approval was based on the Keynote-181 (NCT02559687) and Keynote-180 (NCT02564263) clinical trials. Keynote-181 enrolled 628 patients with recu...
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