FDA OKs Gazyva for new lymphoma indication
On a Roll: FDA OKs Genentech’s Gazyva for Untreated Follicular Lymphoma
By Alex Keown
The regulatory agency approved Genentech’s hemophilia A drug Hemlibra and also approved Gazyva for patients with previously untreated advanced follicular lymphoma. The label expansion is for patients with stage II bulky, III or IV disease, the FDA said in announcing the label expansion. The new FDA approval has Gazyva being used in combination with chemotherapy followed by Gazyva alone for the common blood cancer. Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin’s lymphoma (NHL), is incurable and becomes harder to treat each time it returns. The FDA gave its nod to the label expansion based on the Phase III Gallium study. In that trial, Gazyva showed superior progression-free survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan (rituximab)-based regimen as an initial therapy.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system.
In August, the FDA granted priority review for Gazyva following Genentech’s supplemental Biologics License Application.
Genentech Chief Medical Officer Sandra Horning said the approval of Gazyva is important for those thousands of patients diagnosed with follicular lymphoma “who hope to delay disease progression for as long as possible.” Horning added that Gazyva is a treatment option that is shown to improve upon the company’s own drug Rituxan, which has become a standard –of-care treatment for the disease.
With this approval, Gazyva is available in the United States for three different indications across two common types of blood cancer. The FDA first approved Gazyva in 2013 for people with previously untreated chronic lymphocytic leukemia (CLL). Last year, the FDA also approved Gazyva in combination with bendamustine followed by Gazyva alone as a treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment.
Also yesterday, Genentech saw the approval of its hemophilia A drug Hemlibra which will be used to prevent or reduce the frequency of bleeding episodes in certain patients. Hemlibra will be released with a boxed warning for possible blood clots in patients. The annual hemophilia market is about $11 billion and Genentech hopes its indications of Hemlibra will secure a chunk of that market. With approval of Hemlibra, Genentech will rival drugs FEIBA and NovoSeven, developed by Shire Pharmaceuticals and Novo Nordisk respectively, for a share of the market.