Silas Inman

LOXO-292 Granted Breakthrough Therapy Designation for Lung and Thyroid Cancer

September 05, 2018

The 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 21, 2018

The 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 24, 2018

The 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.

FDA Approves Drug for Chronic Immune Thrombocytopenia

April 18, 2018

Tavalisse (fostamatinib) was granted approval by the Food and Drug Administration (FDA) for patients with chronic immune thrombocytopenia (ITP) after they had an insufficiencent response to another therapy.

Chemo Regimen Helps Control Locally Advanced Pancreatic Cancer

March 23, 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 15, 2018

Ivosidenib (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.