FDA Expands Approval for Companion Diagnostic for Keytruda in Non-Small Cell Lung Cancer
April 17th 2019The Food and Drug Administration expanded the approval for the first and only companion diagnostic to identify patients with non-small cell lung cancer who would benefit from Keytruda treatment.
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FDA Approves First Targeted Therapy to Treat Metastatic Bladder Cancer
April 12th 2019The Food and Drug Administration granted accelerated approval to Balversa to treat locally advanced or metastatic bladder cancer with a type of susceptible genetic alterations known as FGFR3 or FGFR2, in patients who have progressed during or following prior platinum-containing chemotherapy.
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FDA Advisory Committee Votes Against Accelerated Approval of Selinexor for Multiple Myeloma
February 27th 2019The Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 recommending the FDA delay approval of selinexor for the treatment of patients with penta-refractory multiple myeloma until further trial data are available.
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