Leukemias/lymphomas/ And Other Hematologic Cancers
The approval was supported by data from a study in 309 patients (60-75 years of age) with newly diagnosed t-AML or AML-MRC who were randomized to either Vyxeos or daunorubicin and cytarabine separately.
The experimental gene therapy drug was developed by the University of Pennsylvania and Novartis and is called tisagenlecleucel (CTL019)
The TOWER study (n=405) demonstrated a superior improvement in median OS with Blincyto vs. standard of care (SOC) chemotherapy (7.7 months vs. 4 months, hazard ratio [HR] 0.71; P=0.012).
The Food and Drug Administration's Oncologic Drug Advisory Committee has voted in favor that the data from ALFA-0701 has shown a favorable risk-to-benefit for Mylotarg as add-on to chemotherapy for patients with newly diagnosed CD33-positive acute myeloid leukemia.
Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.
Currently available study data demonstrate that Keytruda in combination with pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.
The data informs labs and clinicians on the type of leukemia or lymphoma present by marking proteins found on the surface of cells with fluorescent dyes. These markers are further analyzed on a flow cytometer.
Vidaza is indicated as treatment for myelodysplastic syndrome (MDS), specifically refractory anemias and chronic myelomonocytic leukemia; it can be given either subcutaneously (SC) or intravenously (IV).
The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.
The safety data of the Darzalex combination therapy was similar to the established profile of Darzalex monotherapy and pomalidomide + dexamethasone, respectively.
Doctors were 78% more likely to prescribe a drug to treat metastatic renal cell carcinoma if they'd received a gift or small payment from that drug's manufacturer, compared to physicians who didn't receive any payments.
In the ZUMA-1 trial 42% of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.
Data from an ongoing multicenter, open-label Phase 1/2 trial was presented at the American Society of Hematology in 2016 that evaluated GMI-1271 as adjunct to chemotherapy to patients with relapsed/refractory AML in addition to patients aged ≥60 years with newly diagnosed disease.
To date, there is no approved oral liquid formulation of methotrexate for pediatric patients who require body surface area (BSA) dosing or who have difficulty swallowing or cannot ingest tablets or those with needle-phobia.
The researchers noted that how it is an extraordinary time of new research tools that include electronic health records, technological ability to manage big data, and new functional and structural imaging modalities.
Longer progression-free survival, but no The researchers found that the group that underwent transplantation had significantly longer median progression-free survival compared to the group that received RVD alone difference in overall survival at 4 years.
The study met its primary endpoint of Xgeva non-inferiority versus zoledronic acid in delaying the time to first on-study SRE in multiple myeloma patients (HR=0.98, 95% CI: 0.85, 1.14; P=0.01).
Jazz Pharmaceuticals announced the completion of a rolling submission of the New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin) liposome to the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).
Blincyto is the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
This novel co-formulation combines rituximab (Rituxan) and recombinant human hyaluronidase (rHuPH20), a molecule that helps deliver the drug subcutaneously.
The researchers found that patients with psoriasis had 1.53 times greater risk of developing a malignancy versus patients without psoriasis (P<0.01).