Latest & Greatest

Latest & Greatest

Recent developments in the field of hematology/oncology, including drug approvals, policy updates, and clinical trial results

FDA Revisits Off-Label Communication in Draft Guidance for Medical Product Labeling

Tuesday, March 28th, 2017
In response to requests from drug manufacturers that they be able to communicate supplementary data and information about a product’s “off-label” uses in promotional...

Start-Up Plans to Raise $1 Billion to Develop Liquid Biopsy to Detect Cancer

Tuesday, March 28th, 2017
The biotechnology start-up Grail recently announced its plan to raise $1 billion in financing to create a liquid biopsy assay that could detect cancer...

FDA Grants Priority Review for Inotuzumab Ozogamicin for ALL

Tuesday, March 28th, 2017
The FDA granted priority review for inotuzumab ozogamicin, an anti-CD22 monoclonal antibody, for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphocytic...

Report Finds Americans are Seeking Medications Abroad for Cheaper Prices

Tuesday, March 28th, 2017
When purchased outside the country, many prescription medicines cost less than half of what they do in the United States, driving more Americans to...

Third Patient Death Reported in SL-401 Drug Trial for Patients With BPDCN and AML

Monday, March 27th, 2017
The manufacturers of SL-401, a targeted therapy directed at the interleukin-3 receptor CD123, reported a third patient death in the ongoing phase II trial...

HHS Issues Final Rule on Protecting Human Subjects in Research

Wednesday, March 1st, 2017
The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule to update regulations regarding the use...

FDA Emphasizes Need for Phase III Clinical Trials

Wednesday, March 1st, 2017
A report issued by the FDA noted discrepancies between phase II and phase III drug trials, emphasizing the need for appropriate – and sometimes...

FDA Grants Ibrutinib Accelerated Approval for Marginal Zone Lymphoma

Wednesday, March 1st, 2017
The U.S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib for marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy. The...

NCCN Releases First Set of Guidelines for Myeloproliferative Neoplasms

Monday, February 27th, 2017
The National Comprehensive Cancer Network (NCCN) released its first guidelines for myeloproliferative neoplasms (MPNs), outlining diagnosis, treatment, and supportive care strategies for myelofibrosis (MF)....

FDA Looking to Regulate Stem Cells After Clinics are Caught Marketing Them for Unapproved...

Monday, February 27th, 2017
A study published earlier this year in Cell Stem Cell indicated that at least 351 companies in the United States are marketing unapproved stem cell procedures at...

Current Issue

April 2017, Volume 3, Issue 5

This issue examines the art and science of myeloma drug sequencing, Mikkael Sekeres' letter to the ABIM, highlights from the 16th International Myeloma Workshop, and more.