Genentech and Pharmacyclics receive approval for drugs to treat hematologic malignancies

For the last couple years, the UC San Diego Moores Cancer Center CLL program under the leadership of Dr. Thomas Kipps has been at the forefront of leading clinical trials for the use of ibrutinib (Imbruvica) and obinutuzumab (Gazyva) for patients with CLL.  We are happy to announce that both iburtinub and obinutuzumab have been approved for treatment.  Both drugs are considered “breakthrough therapies” under a program established by Congress last year.  The new Breakthrough Therapy Designation indicates that the medicines may offer substantial improvement over standard treatments for patients with serious or life-threatening diseases.  Both drugs demonstrate a shift  for treatments away from chemotherapy.

Gazyva is an antibody that binds to CD20 a protein found on the surface of B cells and causes the cells, which are cancerous to die.  It is the the first breakthrough monoclonal antibody drug to win FDA approval and will be used to treat patients with CLL who have not been previously treated.  It will be used in combination with chlorambucil to attack cancerous cells.  Patients who participated in the trial demonstrated a significant improvement in progression-free survival with an average of 23 months.  Gazyva is being approved with a boxed warning regarding Hepatitis B virus reactivation and a rare disorder that damages the material that covers and protects nerves in the white matter of the brain (progressive multifocal leukoencephalopathy). These are known risks with other monoclonal antibodies in this class and rare cases were identified in participants on other trials of Gazyva. Patients should be advised of these risks and assessed for Hepatitis B virus and reactivation risk.

Imbruvica was approved for breakthrough treatment for relapses of mantle cell lymphoma and has also recently been applied for approval to treat CLL.  It is an oral treatment and its approval was based the response rates of 111 patients.  65 percent of patients who received Imbruvica had a complete or partial response.  Pharmacyclics officials said the label contained no black box warnings and no contraindications. Safety data during the drug’s pivotal trial showed the most common Grade 3 or 4 nonhematological adverse reactions (≥ 5 percent) included pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue and skin infection

Ibrutinib Approved for treatment of patients with mantle cell lymphoma; Chronic lymphocytic leukemia is not far behind

The FDA approved the use of ibrutinib, now known as Imbruvica, for the treatment of patients with mantle cell lymphoma.  Ibrutinib is the second drug with ‘breakthrough therapy designation’ to receive FDA approval.  This effort is appaluded and supported by the Leukemia and Lymphoma Society (LLS).  We are also proud to mention that the program is lead by former BCRF fellow, Danelle James, MD, MS. (Medical Director for Pharmacyclics)