Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.
Later this year, the Multiple Myeloma Research Foundation and genomic software startup GenoSpace plan to launch a massive data project, called the CoMMpass study, which will follow 1,000 multiple myeloma patients over a 5-year period to help scientists understand the molecular changes underpinning the progression of the disease.
Canada's Aeterna Zentaris took another bad hit today after it announced that it is scuttling a Phase III study of perifosine for relapsed/refractory multiple myeloma. The move came after the drug safety monitoring board decided that there was little to no chance the therapy would meet the hurdle for progression free survival.
Celgene's ($CELG) blood cancer drug Revlimid is on a roll. Already a blockbuster with $3.77 billion in 2012 sales, Revlimid has snagged an approval from Chinese regulators. And the FDA put the drug up for priority review for a new use in patients with mantle-cell lymphoma.
The FDA stamped an approval on Celgene's Pomalyst, a new oral treatment in a growing armament of meds against the blood cancer known as multiple myeloma.
In a preclinical study in human blood cells, Acetylon Pharmaceuticals' selective histone deacetylase (HDAC) 1/2 inhibitor was able to trigger production of fetal hemoglobin, a working form of hemoglobin that is suppressed in adults.
Celgene laid out its case for its multiple myeloma blockbuster hopeful pomalidomide at the American Society of Hematology meeting, boasting of an improved promise of overall survival, progression-free survival and overall response rate among a group of very sick patients who had failed either Revlimid or Velcade.
Takeda has claimed victory with midstage study results for one of the most important experimental meds in its pipeline of cancer drugs, MLN9708, a potential successor to its blockbuster oncology product Velcade. And the program has already advanced to Phase III trials as Takeda's Millennium oncology unit seeks its next multibillion-dollar drug.
Academic and industry researchers could tap the data set to seek individualized treatments, diagnostics and targets for new therapies against cancer.
The data were "highly statistically significant and clinically meaningful," noted Celgene, which is pushing for an approval to use the drug among treatment-resistant patients. The safety review board recommended that patients in the control arm whose myeloma hadn't progressed should be provided the experimental drug combo.