Repotrectinib Expands Treatment Options for Lung Cancers with ROS1 Fusions
NCI » FDA Approvals
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2M ago
The results of the clinical trial that led to FDA’s 2023 approval of repotrectinib (Augtyro) for lung cancers with ROS1 fusions have been published. The drug shrank tumors in 80% of people receiving the drug as an initial treatment ..read more
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Toripalimab Becomes First Immunotherapy Drug Approved for Nasopharyngeal Cancer
NCI » FDA Approvals
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3M ago
FDA approved toripalimab (Loqtorz) based on the results of a large clinical trial showing that, when added to chemotherapy, the drug extended survival in people with nasopharyngeal cancer that returned after initial treatment or spread in the body ..read more
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Enzalutamide Gets Added Approval for Prostate Cancer That Hasn’t Spread
NCI » FDA Approvals
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3M ago
Under a new FDA approval, enzalutamide (Xtandi) can now be used alone, or in combination with leuprolide, to treat people with nonmetastatic prostate cancer that is at high risk of returning after surgery or radiation ..read more
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FDA Amends Approval of Pembrolizumab to Treat Stomach and Esophageal Junction Cancer
NCI » FDA Approvals
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5M ago
FDA has changed its 2021 approval of pembrolizumab (Keytruda) along with trastuzumab (Herceptin) and chemotherapy for treating HER2-positive stomach or GEJ cancer. The agency also announced a new approval of pembrolizumab for HER2-negative forms of these same cancers ..read more
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Quizartinib Approval Adds New Treatment Option for AML, Including in Older Patients
NCI » FDA Approvals
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9M ago
Treatment options for people with acute myeloid leukemia (AML) have expanded yet again. On July 20, FDA approved quizartinib (Vanflyta) combined with chemotherapy as a first-line treatment for AML with a specific change in the FLT3 gene ..read more
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FDA Approves New Initial Treatment Option for Some Metastatic Prostate Cancers
NCI » FDA Approvals
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9M ago
FDA approved enzalutamide (Xtandi) combined with talazoparib (Talzenna) for metastatic castration-resistant prostate cancer with alterations in any of 12 DNA repair genes. The drug combination, which blocks both DNA repair activities and hormones that fuel cancer growth, was more effective than the standard treatment in a large clinical trial ..read more
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Adjuvant Immunotherapy Approved for Some Patients with Lung Cancer
NCI » FDA Approvals
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1y ago
Atezolizumab (Tecentriq) is now the first immunotherapy approved by FDA for use as an additional, or adjuvant, treatment for some patients with non-small cell lung cancer. The approval was based on results of a clinical trial called IMpower010 ..read more
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Carvykti Approval Marks Second CAR T-Cell Therapy for Multiple Myeloma
NCI » FDA Approvals
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1y ago
People with advanced multiple myeloma now have another option for CAR T-cell therapy with the recent approval of ciltacabtagene autoleucel (Carvykti). Like the first approved CAR T-cell therapy, Carvykti targets the BCMA protein on myeloma cells ..read more
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