Miscellaneous Hematological Agents

Risk for Zoster Up Before Dx, During Tx of Hematologic Cancer

December 17, 2018

The risk for herpes zoster (zoster) is elevated during the two years preceding diagnosis and during treatment of hematological cancer.

FDA: Serious Side Effect of AML Drug Not Being Recognized

By November 30, 2018

From May 1 2018 to July 31 2018, 5 cases of death associated with DS in patients taking Idhifa have been reported; in 2 of these cases, DS was listed as the only cause of death.

Xospata Approved for Relapsed/Refractory AML With FLT3 Mutation

By November 29, 2018

Xospata was evaluated in the Phase 3 open-label, multicenter, randomized ADMIRAL trial (N=138) which included patients with relapsed or refractory AML with a FLT3 ITD, D835, or I836 mutation.

First Rituximab Biosimilar Truxima Gets FDA Approval

By November 29, 2018

The FDA approval was supported by clinical data describing structural and functional characterization, preclinical data, human pharmacokinetic data, clinical immunogenicity data, and other data which showed no clinically meaningful differences between Truxima and Rituxan.

Recommended Therapies for Polycythemia Vera Underused

November 28, 2018

Phlebotomy and hydroxyurea tied to improved survival, lower risk for thrombosis in older patients

Adcetris Plus Chemotherapy Approved for Peripheral T-Cell Lymphoma

By November 16, 2018

The approval was based on data from a randomized, double-blind, double-dummy, actively controlled trial (ECHELON-2) involving 452 patients with certain PTCLs.

Red Cross Issues Urgent Call for Blood Ahead of the Holidays

November 15, 2018

More than 4300 blood drives are needed to help stop the shortage from continuing throughout the winter, so the Red Cross is asking organizations to host blood drives in December, January, and February. I

Can Omega-3 Help Reduce MACE in High Risk Patients With Hypertriglyceridemia?

November 13, 2018

In high-risk patients with mild hypertriglyceridemia, omega-3 fatty acids improved triglyceride levels and reduced major adverse cardiovascular events, according to a new meta-analysis.

Jakafi Granted Priority Review for Acute Graft-Versus-Host Disease

By October 25, 2018

The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD.

STRO-001 Gets Orphan Drug Designation for Mutiple Myeloma

By October 12, 2018

STRO-001 targets CD74, which is a protein highly expressed in B-cell malignancies like multiple myeloma.

High Flow Nasal Cannula Oxygen Tx May Benefit Elderly Patients in ICU

October 12, 2018

After high flow nasal cannula oxygen therapy, 15% of patients had to be intubated and mechanically ventilated, but the majority stepped down to regular oxygen therapy.

Tegsedi Approved for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

By October 09, 2018

The approval was based on data from the Phase 3 NEURO-TTR study (N=173) which randomized patients with polyneuropathy caused by hATTR amyloidosis to Tegsedi or placebo.

Superwarfarin contaminants found in cannabinoid-associated coagulopathy outbreak

October 04, 2018

During one month at a single medical center in Illinois in 2018, 34 cases of synthetic cannabinoid associated coagulopathy were identified.

FDA Approves New Dosing Option for Kyprolis in Multiple Myeloma

By October 01, 2018

The approval was based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that Kyprolis 70mg/m2 once-weekly plus dexamethasone achieved superior progression-free survival (PFS) compared with Kyprolis 27mg/m2 twice-weekly with dexamethasone (median PFS: 11.2 months vs 7.6 months; hazard ratio [HR] 0.69; 95% CI, 0.54-0.88; one-sided P=.0014).

Oral Syk/JAK Inhibitor Gets Orphan Drug Designation for Peripheral T-Cell Lymphoma

By September 28, 2018

Preclinical data has suggested that Syk and JAK play important roles in PTCL tumor survival.

New Risk Factors Identified for Varicose Vein Disease

September 25, 2018

Researchers applied machine learning to agnostically search for varicose vein risk factors in a cohort of 493,519 individuals in the UK Biobank.

First-in-Class Treatment Approved for Hairy Cell Leukemia

By September 14, 2018

The approval of Lumoxiti was based on data from a Phase 3 single-arm, open-label trial conducted in patients with histologically confirmed HCL or HCL variant with a need for therapy based on presence of cytopenias or splenomegaly and who had received prior treatment with at least 2 systemic therapies, including a purine nucleoside analog (N=80).

Venclexta Labeling Updated With Minimal Residual Disease Negativity Data

By September 11, 2018

MRD-negativity is defined as <1 CLL cell per 10,000 lymphocytes detected in the blood or bone marrow using sensitive analytical models.

Imbruvica Plus Rituximab Approved for Waldenström's Macroglobulinemia

By August 27, 2018

This expanded approval was based on results from the iNNOVATE study, a double-blind, placebo-controlled trial evaluating Imbruvica in combination with rituximab vs placebo + rituximab in 150 patients with either relapsed/refractory disease or previously untreated Waldenström's macroglobulinemia.

AML Treatment for Patients Over 60 Gets Fast Track Designation

By August 27, 2018

CX-01 is designed to block the activity of chemokines that support the resistance of blood cancers to treatment and that contribute to the delay of bone marrow recovery after chemotherapy.

Accuracy of Hypoxia-Based Baby Monitors Is Concerning

August 22, 2018

"As more neonate and infant vital sign monitors emerge in this largely unregulated market, physicians and parents should exercise caution incorporating data from these monitors into medical decisions."

CPI-613 Gets Orphan Drug Designation for Peripheral T-Cell Lymphoma

By August 17, 2018

This first-in-class drug was previously granted Orphan Drug designation for the treatment of pancreatic cancer, acute myeloid leukemia, Burkitt lymphoma, and myelodysplastic syndromes.

Elzonris Granted Priority Review for Blastic Plasmacytoid Dendritic Cell Neoplasm

By August 14, 2018

The Company announced results from a Phase 2 trial involving 45 patients with BPDCN earlier this year.

Supplemental BLA Submitted for Darzalex Split Dosing Regimen

By August 09, 2018

The proposed dosing regimen would provide the option of splitting the first infusion of Darzalex over 2 consecutive days.

Treatment for FLT3-ITD Acute Myeloid Leukemia Gets Breakthrough Designation

By August 02, 2018

The designation was based on results from the Phase 3 QuANTUM-R trial, which included 367 participants who were randomized to receive quizartinib or salvage chemotherapy (SC).

Anti-CD47 Antibody Granted Orphan Drug Designation for Multiple Myeloma

By August 01, 2018

SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis.

Tibsovo Approved for Relapsed/Refractory AML With IDH1 Mutation

By July 20, 2018

The approval of Tibsovo was based on an open-label, single-arm, multicenter clinical trial (Study AG120-C-001) involving 174 patients with relapsed or refractory AML with an IDH1 miutation.

Galinpepimut-S Fast-Tracked for Multiple Myeloma Treatment

By July 20, 2018

As WT1 is present in an array of tumor types, the Company believes GPS has the potential to be a broad immunotherapy.

<small>L</small>-Glutamine Reduces Number of Pain Crises in Sickle Cell Disease

July 19, 2018

The researchers found that there were significantly fewer pain crises in the L-glutamine group than in the placebo group, with a median of 3.0 and 4.0, respectively.

Bone Marrow Transplant Alternative Granted Orphan Drug Designation

By July 17, 2018

It is also the first bone marrow transplant alternative to be granted Breakthrough Therapy status by the FDA.