Arzerra (Humax-CD20) approved

beardedirisesI am pleased to report that finally Arzerra (Humax-CD20) has been approved by the FDA for treatment of refractory CLL. Since this accelerated approval was based on a clinical trial cohort of patients who were fludarabine refractory and Campath refractory (or ineligible), the FDA approval is for treatment of that group of patients.

However, now that the drug will be available commercially in a few weeks (see below), it is up to you and your doctors to decide if this drug is right for your individual situation. All of us who have been around the block more than a few times are very aware of use of drugs outside of the narrow guidelines of the FDA approval. Rituxan (the previous generation anti-CD20 monoclonal antibody) has been used as a single agent in front line therapy of CLL patients for several years now – even though it has never received formal approval from the FDA for that purpose.

In other words, sit down and have an informed talk with your healthcare providers about what is the right therapy option for you. That is good advice in any case, whether or not Arzerra is in your future. This site and our flagship website www.clltopics.org have many articles regarding Arzerra, all you have to do is search for them using the key phrase “Humax-CD20”

This is a bitter sweet moment for me. My husband PC and I fought for this approval for several years. He was fortunate to get compassionate use access to Humax-CD20 back in 2006 and we were impressed how well it worked for him. Back then we had to travel all the way to Bournemouth (UK) to get this drug administered. Now, in a few weeks, you can get it infused in the comfort of your local oncologist’s backroom. I am sorry PC is not here to celebrate this development, it is truly a victory for our patient community. He would have been proud.

GSK AND GENMAB RECEIVE ACCELERATED APPROVAL FOR ARZERRA

Philadelphia, PA and Copenhagen, Denmark; October 26, 2009 – Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of ArzerraTM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.

The approval is based on results from a pivotal study in which 42% of patients with CLL who were refractory to both fludarabine and alemtuzumab (two therapies used in treating CLL) responded to treatment with Arzerra. These patients had a median duration of response of 6.5 months. The most common adverse reactions (≥10%) seen were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.

Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. Arzerra attaches to the small and large loop epitopes – on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

The approval of Arzerra was supported by a positive recommendation by the FDA’s Oncologic Drugs Advisory Committee (ODAC) at ASCO on May 29, 2009, in which the panel voted, 10-3, that the Arzerra data were likely to predict clinical benefit for patients with CLL whose disease is refractory to fludarabine and alemtuzumab.

Arzerra is anticipated to be available for prescription use in the coming weeks.

GSK has added Arzerra to its expanding patient assistance program, Commitment to Access, and has expanded the program. This program assists eligible patients, with or without insurance, with paying for cancer medicines. For more information about the program, visit www.CommitmentToAccess.com or call 1-8ONCOLOGY1 (1-866-265-6491).

Ofatumumab