August 20, 2020: Genmab Announces Plan to Transition Arzerra® (ofatumumab) to an Oncology Access Program for Chronic Lymphocytic Leukemia Patients in the U.S. There are 4 monoclonal antibodies approved to treat CLL, but in reality, only 2 of them, rituximab and Obinutuzumab (Gazyva)... August 20, 2020Business, Finances, Insurance & RegulatoryBy Brad Hedrick
FDA Clearance for clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia (CLL) This is good news for CLL patients as measurement for MRD (minimal or measurable residual disease) is increasingly being recognized... August 11, 2020Business, Finances, Insurance & Regulatory, MRD & Disease MonitoringBy Brad Hedrick
Gilead Gets Another CAR-T Approval, This Time for Mantle Cell Lymphoma Hopefully the next approval will be for CLL patients, but there is still much work to be done in clinical... July 27, 2020Business, Finances, Insurance & Regulatory, CAR-TBy Brad Hedrick
Proposed Changes to Reimbursement to Help Pay for CAR-T Therapy for Patients Covered by Medicare or Medicaid May 15, 2020 CAR-T is an essential new treatment opportunity for patients. In my personal experience, I have no measurable leukemia... May 18, 2020Business, Finances, Insurance & Regulatory, CAR-TBy Brad Hedrick
A Petition to CMS for Medicare Reimbursement for Use of CAR-T CAR-T is a potent and helpful option for many blood cancer patients, but Medicare and Medical insurance coverage can be... April 27, 2020Business, Finances, Insurance & Regulatory, CAR-TBy Brad Hedrick
New Indication for Ibrutinib 4/22/2020 Ibrutinib already had 5 indications for the treatment of CLL and now has received its 6th for use in combination... April 24, 2020Business, Finances, Insurance & RegulatoryBy Brad Hedrick
New Test Approved for Payment by Medicare for Measuring Minimal Residual Disease (MRD) in Chronic Lymphocytic Leukemia or CLL Looking with greater and greater accuracy for persistent cancer cells can help better inform when to stop and maybe when... January 12, 2020Business, Finances, Insurance & Regulatory, MRD & Disease MonitoringBy Brad Hedrick
The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL) Acalabrutinib is already approved to treat mantle cell lymphoma, but with BTD for CLL, that means it is one step... August 15, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Shuttering of the Biden Cancer Initiative The cancer moonshot lead by VP Joe Biden started with such promise, but it is on hold now due to... August 5, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Approval of a biosimilar for Rituximab The approval of Ruxience (rituximab-pvvr) (Pfizer) a biosimilar for the originator product Rituxan (Genentech) brings the total number of FDA... July 29, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
