The Food and Drug Administration (FDA) has given its blessing to Beleodaq, a new drug that is designed for treating patients with peripheral T-cell lymphoma (PTCL), a rare but dangerous type of non-Hodgkin's lymphoma.
Spectrum Pharmaceuticals developed Beleodaq as a treatment for PTCL, a group of diseases characterized by cancerous lymph nodes. It is designed as treatment for patients who did not respond to initial forms of treatment and those whose PTCL relapsed after treatment. Beleodaq's effectiveness stems from its ability to inhibit the production of enzymes that cause T-cells, a type of immune cells, to become cancerous.
"This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma," says Dr. Richard Pazdur, Office of Hematology and Oncology Products director of the FDA's Center for Drug Evaluation and Research. "Today's approval expands the number of treatment options available to patients with serious and life-threatening diseases."
The drug received the nod from the FDA under accelerated approval, the agency's programs for drugs that exhibit benefits for patients of serious conditions with little to no treatment available. Under accelerated approval, the drug will still have to undergo trials regarding its efficacy.
In this case, Beleodaq has been proven effective in treating 25.8% of 129 patients who either had a relapse or did not respond to earlier treatments. The patients continued to receive the drug until their situation worsened or the side effects became unbearable. So far, a number of side effects have been recorded, including fever, nausea, fatigue, vomiting and low red blood cell count.
PTCL comprises 10% to 15% of all non-Hodgkin's lymphoma cases in the United States. The National Cancer Institute says more than 70,000 Americans will be diagnosed with PTCL this year and nearly 19,000 patients will die from the same disease.
Beleodaq is the third drug to be approved for patients with relapsed or refractory PTCL, following romidepsin with brand name Istodax by Celgene Corporation in 2011 and pralatrexate or Folotyn also by Spectrum in 2009.
Nevada-based Spectrum has suffered a blow following declining sales of its best-selling drug Fusilev, which is prescribed for treating patients with colon cancer, after the rise of low-cost generic medicines for the same condition. Earlier this year, Spectrum acquired Talon Therapeutics and began selling Marqibo under its banner. The drug is used for treating recurring leukemia. The company also sells a fourth drug called Zevalin for another kind of non-Hodgkin's lymphoma.
Shares of Spectrum went up by 5.5% to $9.20 in late-morning Nasdaq trading following the FDA's announcement.
