Committee Votes in Favor of RA Drug Despite Lymphoma Concerns

Major pharmaceutical company Pfizer is announcing today that the US Food and Drug Administration's Arthritis Advisory Committee has voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The FDA will consider the Committee's recommendation when it reviews Pfizer's New Drug Application (NDA) for tofacitinib. The FDA isn't beholden to the Committee's vote, but it generally takes its recommendation.

Call

If the Agency approves tofacitinib, it would be the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.

“We are pleased with the Committee's positive evaluation of the tofacitinib data and its decision to recommend approval,” said Dr. Yvonne Greenstreet, senior vice president and the head of Medicines Development Group for Pfizer Specialty Care. “The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application.”

This is a somewhat surprising recommendation considering the concerns that had been expressed prior to the meeting, concerns that included what some considered an unacceptably high incidence of lymphoma among participants in clinical trials for the drug.

Source: Therapeutics Daily

Call

More Articles

More Articles

This entry looks at Non Hodgkin's Lymphoma in the lungs, clinically known as pulmonary lymphoma, one of the subtypes of lymphoma. 'Lymphoma' is an...

In order to prevent developing any subtype of lymphoma, it would be helpful to know the causes of lymphoma. Unfortunately, in virtually every case...

BEAM chemotherapy is an acronym representing a small family of combination chemotherapy regimens that are used chiefly as salvage regimens in the...

There are two types of cancer: benign and malignant. Benign cancers are the kind that don't spread and don't threaten one's life. Malignant...

The Erythrocyte Sedimentation Rate (ESR - sometimes called sed rate or sedimentation rate) is a nonspecific screening test for various...

Blood counts can be used to identify disease and monitor patient health during cancer treatments. Though these tests cannot diagnose lymphoma on...

MALT lymphoma is a rare B-cell non-Hodgkin's lymphoma that typically runs an indolent or slow-growing clinical...

Mantle cell lymphoma (MCL) is just one of 50-60 known B-cell subtypes of...

After some of the dust has settled, the thoughts of many new lymphoma patients turn to diet and nutrition. They want to know if, in the past,...

According to a study by Japanese researchers, the SMILE combination chemotherapy protocol is effective against extranodal natural killer/T-cell...

In a perfect world, every case of cancer would respond to, and be cured by first-line therapy. Unfortunately, it is not often the case. This is...

Patients treated with maintenance rituximab had three times longer progression-free survival. This is a summary of an article published in the...

Prednisone is a glucocorticosteroid (a steroid) used in the treatment of many types of cancers. It functions as an anti-inflammatory medicine that...

In 1964, researchers at the National Cancer Institute developed the first combination chemotherapy that cured a...

Since so many chemotherapy agents can affect a patient’s sex drive and fertility, thinking about these issues prior...