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FDA Approves Drug Duo for BRAF-Positive Melanoma
June 27th 2018The FDA has approved the combination of the BRAF inhibitor Braftovi (encorafenib) and the MEK inhibitor Mektovi (binimetinib) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.
Novel Drug Granted Priority Review for Acute Myeloid Leukemia Treatment
June 27th 2018The Food and Drug Administration (FDA) has granted a priority review to a new drug application (NDA) for glasdegib to treat patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), which is a type of chemotherapy, according to Pfizer, the manufacturer of the drug.
Small Percentage With Myelofibrosis Develop Aggressive Lymphoma from JAK Inhibition
June 25th 2018While JAK inhibitors have proven to be an effective treatment for patients with myelofibrosis, a type of myeloproliferative neoplasm (MPN), they may come with a severe downside – in particular, a 16-fold increase in the chance of developing a B-cell lymphoma, according to recent research published in the journal Blood.
Keytruda Granted sBLA for Melanoma Treatment
June 25th 2018The FDA has accepted a supplemental biologics license application (sBLA) for the use of Keytruda (pembrolizumab) as an adjuvant treatment for patients with resected, high-risk stage 3 melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor.
Drug Duo Granted Priority Review to Treat Waldenstrom Macroglobulinemia
June 25th 2018The FDA has granted a priority review to a supplemental new drug application (sNDA) Imbruvica (ibrutinib) for use in combination with Rituxan (rituximab) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.
Insurance Disparities Among Medicaid Patients with NSCLC Leads to Worse Survival
June 21st 2018According to findings from the ASCO Annual Meeting, insurance disparities still exist, and may even contribute to cancer-specific and comorbidity-associated mortalities in patients with early-stage non-small cell lung cancer.
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.