Tumor-Infiltrating Lymphocyte Decreases Death Risk in Unresectable Skin Cancer
September 13th 2022The use of a tumor-infiltrating lymphocyte therapy led to better outcomes than treatment with Yervoy in patients with unresectable, treatment-refractory stage 3/4 melanoma, a type of skin cancer, study results showed.
LOXO-292 Granted Breakthrough Therapy Designation for Lung and Thyroid Cancer
September 5th 2018The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with RET fusion–positive non–small cell lung cancer (NSCLC) or RET-mutant medullary thyroid cancer (MTC). This designation will expedite the development and review of the drug.
FDA Updates Immunotherapy Labels for Bladder Cancer Treatment
June 21st 2018The FDA has incorporated PD-L1 status into the labels for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma, based on lower overall survival (OS) rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.
FDA Approves Combination Treatment for Metastatic Prostate Cancer
May 24th 2018The Food and Drug Administration (FDA) approved a new formulation of Yonsa (abiraterone acetate) in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC), according to Sun Pharma, the company commercializing the treatment.
Chemo Regimen Helps Control Locally Advanced Pancreatic Cancer
March 23rd 2018“Disease control is key in our patients with locally advanced disease, as it may lead to opportunities for additional treatment interventions, including radiotherapy, or even, in some favorable cases, surgical resection,” said lead study author Pascal Hammel, M.D., Ph.D.
Ivosidenib Granted FDA Priority Review for AML Treatment
February 15th 2018Ivosidenib (AG-120) was granted a priority review designation by the Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
Gilotrif's Approval Expanded to Some Patients With Metastatic NSCLC
January 15th 2018The Food and Drug Administration (FDA) expanded the approved use for Gilotrif (afatinib). The drug can now be used to treat patients with metastatic non-small cell lung cancer (NSCLC) who have uncommon EGFR alterations in L861Q, G719X and/or S768I.
FDA Grants Priority Review for Rare Neuroendocrine Tumor Treatment
January 2nd 2018The Food and Drug Administration (FDA) granted a priority review designation to a novel version of Azedra (iobenguane I-131), a radiopharmaceutical, to treat patients with malignant or recurrent pheochromocytoma or paraganglioma (PPGL).
Four-Drug Combination Improves NSCLC Outcomes
December 24th 2017A four-drug combination, including Tecentriq (atezolizumab), Avastin (bevacizumab), carboplatin and paclitaxel, delayed progression or death by 38 percent in patients with advanced non-squamous non–small cell lung cancer (NSCLC), compared to those who were treated with Avastin alone.
Perjeta Combination Granted FDA Approval for Breast Cancer
December 21st 2017The FDA has approved Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence, based on findings from the APHINITY trial.