http://www.raredr.com/news/obinutuzumab-follicular-lymphoma-approved
FDA Gives Go-Ahead to Obinutuzumab for Follicular Lymphoma Treatment

Mathew Shanley

On the same day that Genentech received U.S. Food and Drug Administration (FDA) approval for emicizumab as a therapy for hemophilia A patients, the regulatory agency has also given the green light to Gazyva (obinutuzumab) to treat follicular lymphoma.

The second of Genentech’s two approvals today is indicated for use in follicular lymphoma patients in combination with chemotherapy and followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stages II bulky, III or IV). The approval is based on results from the Phase III Gallium study.

Data from the Phase 3 Gallium study were published in the New England Journal of Medicine in October, and concluded that the company’s combination therapy exhibited greater progression-free survival (PFS) than patients who received a Rituxan (rituximab)-based regimen as an initial, or first-line, therapy.

Follicular lymphoma is the most frequently-occurring indolent type of non-Hodgkin lymphoma. It progresses slowly and is characterized by cycles of remission and relapse, and common symptoms including the swelling of lymph nodes in the neck, underarms, abdomen, or groin. Flu-like symptoms are also common in patients, and night sweats have been reported as an early indicator in some cases.

“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development in the official press release. “We’re pleased we can now offer patients with this incurable blood cancer an initial treatment option shown to improve upon Rituxan, the standard of care in this setting for more than 10 years.”

With this approval, Gazyva is now available in the U.S. for 3 different indications across 2 common blood cancer types. The therapy is also a prescription medication used in: adults with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment; with the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

The boxed warning for the drug notes that Gazyva can cause side effects that can become serious or life-threatening, including hepatitis B virus and progressive multifocal leukoencephalopathy (PML). Additional adverse events (AEs) commonly seen in patients who received Gazyva included: infusion reactions, low white blood cell count, fever, cough, nausea and diarrhea, and low platelet count.

For more breaking news from the FDA, follow Rare Disease Report on Facebook and Twitter.
Printer Printing...
$content$