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The approval is based on data from CASSIOPEIA, an open-label, randomized, active-controlled phase 3 study.
Recent legislation may help narrow the gap between FDA approval of cancer medications for adults and children.
Keytruda plus Lenvima is first approval under Project Orbis collaboration.
AACR report highlights progress in preventing and treating cancer—including 27 new drug approvals last year—but disparities persist.
Two androgen receptor inhibitors improved survival by 33% in men with metastatic prostate cancer that responds to hormone therapy.
FDA approves Nubeqa for nonmetastatic prostate cancer
FDA approves Rozlytrek for cancers with certain gene mutations
This is the second drug the FDA has approved for myelofibrosis; the first came in 2011.
New site-agnostic therapy shrank tumors in people with a variety of cancers with NTRK gene fusions as well as ROS1-positive lung cancer.
Though seldom malignant, tenosynovial giant cell tumors can damage joints and tendons.
The androgen receptor inhibitor delayed cancer metastasis in a late-stage clinical trial.
pembrolizumab’s efficacy was investigated in two clinical trials of people with recurrent, locally advanced or metastatic disease.
First nuclear export inhibitor gets the nod for patients lacking treatment options.
Darzalex in combination with lenalidomide and dexamethasone is for people who are ineligible for an autologous stem cell transplant.
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