Glasdegib, a Hedgehog Inhibitor, Nearly Doubles Survival in Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Adding the investigational smoothened (SMO) receptor inhibitor glasdegib to low-dose cytarabine (DepoCyt) significantly increased overall survival (OS) compared with low-dose cytarabine monotherapy in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who were ineligible for intensive chemotherapy, according to a phase 2 study presented by Jorge E. Cortes, MD, Department of Leukemia, M.D. Anderson Cancer Center, Houston, TX, at the 2016 American Society of Hematology meeting.
A new economic model suggests that overall survival and drug toxicity profiles are insufficient for assessing the value of a drug. According to a study that incorporated late adverse events in advanced Hodgkin lymphoma, a more comprehensive benefit-to-risk ratio of a drug requires an understanding of its long-term health implications, said Ohad Oren, MD, Pennsylvania Hospital, University of Pennsylvania, Philadelphia, at the 2016 American Society of Hematology meeting.
- Rubraca Approved for Advanced Ovarian Cancer with BRCA Mutations
- Avastin Approved for Platinum-Sensitive Ovarian Cancer
- Darzalex Approved for Use in Combination with Standard Regimen for Multiple Myeloma
- Opdivo Now Approved for Head and Neck Squamous-Cell Carcinoma
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda injection) for use in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-containing chemotherapy. The injection is recommended to be administered at 200 mg intravenously for 30 minutes every 3 weeks.
Daclizumab (Zinbryta) has been approved by the US Food and Drug Administration for adults with relapsing forms of multiple sclerosis. The drug is self-administered by the patient monthly, and comes in the form of a long-acting injection.
The US Food and Drug Administration has approved Netspot, the first kit for preparation of gallium Ga 68 dotatate injection, for the detection of neuroendocrine tumors in adult and pediatric patients. The injection serves as a radioactive diagnostic agent for positron emission tomography imaging.
The first blood test for detecting epidermal growth factor receptor (EGFR) gene mutations in patients with non−small-cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration. The cobas EGFR Mutation Test v2 is a blood-based diagnostic that aids in selecting patients with NSCLC who may benefit from treatment with erlotinib (Tarceva).
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Results 131 - 140 of 187
Results 131 - 140 of 187