Leukemias/lymphomas/ And Other Hematologic Cancers

Vyxeos Approved for Two Types of Acute Myeloid Leukemia

By August 03, 2017

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.

Idhifa Approved for Relapsed/Refractory AML with IDH2 Mutation

By August 01, 2017

The drug carries a Boxed Warning regarding the risk of differentiation syndrome.

Xatmep Now Available for Pediatric ALL, pJIA

By July 31, 2017

Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication.

First Gene Therapy Drug Under FDA Expert Panel Review

July 13, 2017

The experimental gene therapy drug was developed by the University of Pennsylvania and Novartis and is called tisagenlecleucel (CTL019)

FDA Expands Blincyto Use for B-cell Precursor ALL

By July 12, 2017

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).

FDA Committee in Favor of Mylotarg for AML

By July 12, 2017

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.

Cancer Peptide Vaccine Designated Orphan Drug for MDS

By July 10, 2017

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.

Addition of Antifungal to Cancer Tx Leads to Nephrotic Syndrome

July 07, 2017

Case report of patient with relapsed Hodgkin's lymphoma treated with everolimus for five years

Multiple Myeloma Studies Evaluating Keytruda Put on Clinical Hold

By July 06, 2017

Currently available study data demonstrate that Keytruda in combination with pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.

FDA Approves Test to Detect Several Blood Cancers

By June 30, 2017

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.

Breckenridge Approved for Generic Vidaza

By June 29, 2017

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).

Rituxan Biosimilar BLA Accepted for FDA Review

By June 29, 2017

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.

Addition of Midostaurin to Chemo Assessed for Overall Survival in AML

June 26, 2017

Prolonged overall, event-free survival for patients with acute myeloid leukemia, FLT3 mutation

FDA Approves New Combo Regimen for Refractory Multiple Myeloma

By June 19, 2017

The safety data of the Darzalex combination therapy was similar to the established profile of Darzalex monotherapy and pomalidomide + dexamethasone, respectively.

Gifts From Drug Manufacturers Influence Clinician's Rx Choices

June 07, 2017

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.

Vyxeos Granted Priority Review by FDA

By May 31, 2017

Vyxeos, or CPX-351, combines cytarabine and daunorubicin in a nano-scale liposome at a 5:1 molar ratio using the CombiPlex platform.

Priority Review Granted for Axicabtagene Ciloleucal in NHL

By May 26, 2017

In the ZUMA-1 trial 42% of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.

AML Drug Candidate Granted Breakthrough Therapy Designation

By May 17, 2017

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.

Generic Clolar Available from Fresenius Kabi

By May 16, 2017

Clofarabine Injection is supplied as single-dose vials containing 20mg per 20mL of clofarabine.

Could Movies Act as an Alternative Anesthetic?

May 10, 2017

Videos promote relaxation and stillness without medication, researchers say

Rydapt Approved for Acute Myeloid Leukemia, Mastocytosis

By April 28, 2017

Rydapt works by inhibiting multiple receptor tyrosine kinases.

Xatmep Approved for Pediatric Patients with pJIA, ALL

By April 26, 2017

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.

Researchers Predict Next 7 Great Advances in Pediatric Healthcare

April 24, 2017

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.

FDA: Prescribing Change for ESAs

By April 13, 2017

The decision was made based on data which showed that clinicians demonstrated acceptable knowledge of the product risks.

Combo RVD Tx Plus Stem-Cell Transplantation Assessed in Multiple Myeloma

April 07, 2017

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.

Amgen Looks to Expand Xgeva Use to Multiple Myeloma Patients

By April 05, 2017

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).

FDA to Review Vyxeos for Acute Myeloid Leukemia

By April 03, 2017

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 Gains Priority Review for sBLA

By March 31, 2017

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.

Novel Co-Formulation for Blood Cancers Gets FDA Committee Nod

By March 29, 2017

This novel co-formulation combines rituximab (Rituxan) and recombinant human hyaluronidase (rHuPH20), a molecule that helps deliver the drug subcutaneously.

Psoriasis May Up Melanoma, Hematologic Cancer Risk

March 28, 2017

The researchers found that patients with psoriasis had 1.53 times greater risk of developing a malignancy versus patients without psoriasis (P<0.01).