Genentech, Biogen Receive Complete Response From FDA For Rituxan

Genentech, a wholly-owned member of the Roche Group and Biogen Idec have received a complete response from the FDA for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

Reportedly, the FDA has indicated that they do not believe an approval for Rituxan (in people with RA who have not previously received MTX or those who were MTX inadequate responders) can be supported at this time due to the rare risk of progessive multifocal leukeoencephalopathy (PML) in light of the number of effective RA treatments currently available to patients in earlier stages of the disease. Although the incidence of PML in RA patients treated with Rituxan is rare there are no known reliable PML treatments.

The company has said that the FDA approved an additional sBLA submission to include updated safety and efficacy data in the label that provides guidance on how later-stage patients, those who have inadequately responded to tumor necrosis factor (TNF)-antagonist therapies, can be retreated with Rituxan. It’s ability to improve physical function and slow joint damage for up to two years as demonstrated in clinical studies has also been added.

However, the current indications for Rituxan in certain blood cancers remain unchanged. Additionally, the companies remain committed to their development programs for other anti-CD20 molecules in both oncology and immunology.

Hal Barron, executive vice president, global development and chief medical officer at Genentech, said: “We are committed to patient safety and understand the Agency’s decision, given the uncertainty regarding the risk of PML, and we will discuss next steps with the FDA to determine an appropriate path forward. We are encouraged by the FDA’s decision to support retreatment for people in later stages of RA and continue to believe that Rituxan is effective in this setting.”

David Hagerty, vice president and chief medical officer, rheumatology, Biogen, said: “In more than eight large studies conducted, Rituxan has demonstrated that it can improve the symptoms of RA, an often debilitating disease. Patients living with moderate-to-severe RA who have limited treatment options continue to benefit from Rituxan.”