Tesaro's Niraparib Approved for Ovarian Cancer Maintenance Therapy

Tesaro's niraparib has received approval in the United States as a maintenance therapy for ovarian cancer, specifically for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a complete or partial response to platinum chemotherapy. Marketed under the name Zejula, this poly-ADP ribose polymerase (PARP) inhibitor is anticipated to achieve peak sales of approximately $2 billion.

Key Highlights:

• First PARP Inhibitor for Maintenance Therapy: Zejula is the first PARP inhibitor approved for maintenance therapy in ovarian cancer, a significant milestone after AstraZeneca’s Lynparza failed to impress an FDA expert panel for this indication in 2014.
• No Biomarker Test Required: Unlike other treatments, Zejula does not require a biomarker test for patient selection, which is a setback for Myriad Genetics, which had advocated for its companion diagnostic test.
• Expansion into Other Uses: Tesaro is exploring the development of Zejula in combination with other therapies, including an anti-PD-1 antibody for first-line ovarian cancer maintenance treatment and with Roche’s Avastin for patients with the first recurrence of the disease.
• Challenges in Breast Cancer Trials: The BRAVO study, assessing Zejula in breast cancer with BRCA mutations, faced challenges as a significant number of patients in the chemotherapy arm discontinued the trial, preferring treatment with rival PARP inhibitors. This has led to uncertainty about the trial's continuation.

Tesaro's commitment to advancing Zejula's application across various cancer types underscores the potential of PARP inhibitors in transforming cancer treatment paradigms. Despite the hurdles in breast cancer trials, the approval for ovarian cancer maintenance therapy represents a pivotal achievement for Tesaro and offers new hope for patients battling this challenging disease.