FDA Approves Zejula ( NIraparib ) as Maintenance Therapy for Ovarian, Other Women’s Cancers

Mar 29, 2017

La Administración de Alimentos y Fármacos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó el medicamento Zejula (niraparib) para mujeres con algunos tipos de cáncer de ovario, trompa de Falopio o peritoneal .

 Este es el tercero de este tipo de fármaco, llamado inhibidor de la PARP, aprobado para tratar a las mujeres con cáncer de ovario. 

Pero a diferencia de los otros dos fármacos, el uso de Zejula no se limita a las mujeres con una mutación BRCA . Está aprobado para las mujeres cuyo cáncer ha vuelto después de recibir quimioterapia ...

The United States has approved Tesaro’s Zejula (niraparib) as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The Federal Drug Administration sign-off indicates that regulators believe Zejula’s can delay cancer growth in patients who have shown a complete or partial response to platinum-based chemotherapy.

“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” the FDA’s Richard Pazdur, MD, said in a press release. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”

Pazdur is acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He is also director of the FDA’s Oncology Center of Excellence.

The National Cancer Institute estimates that in 2017 more than 22,000 women will be diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer, and more than 14,000 patients will die of those cancers.

Zejula, is an oral, once-a-day poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor. It the only one of this class of drugs the FDA has approved as a maintenance therapy for women with recurrent ovarian, fallopian, or primary peritoneal cancers.

Zejula’s effectiveness and safety were evaluated in a double-blind, placebo-controlled, international Phase 3 trial known as NOVA (NCT01847274).

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