FDA Approves Nerlynx-Xeloda Combo For HER2-Positive Breast Cancer

The Food and Drug Administration (FDA) has approved a supplemental new drug application for Nerlynx (neratinib) in combination with Xeloda (capecitabine) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2 based therapies in the metastatic setting.

The approval for the combination of Nerlynx and Xeloda comes off the heels of the phase 3 NALA trial that looked at the efficacy of Nerlynx in combination with Xeloda, which found a significant improvement in patient’s progression free survival (the time from treatment to disease progression or worsening) compared to Tykerb (lapatinib) in combination with Xeloda. The progression free survival rate at 12 months for patients receiving Nerlynx and Xeloda was 29% compared to 15% for those receiving Tykerb and Xeloda.

“Together with the NALA investigators around the world, I am pleased to see the FDA approval of Nerlynx for the treatment of advanced HER2-positive metastatic breast cancer,” Dr. Adam M. Brufsky, of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center, stated in a press release. “This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to Nerlynx’s established role in the treatment of early breast cancer.”

The NALA trial is a global multicenter randomized trial that looked at 621 patients with metastatic HER-2 positive breast cancer. Researchers also found that fewer patients on Nerlynx and Xeldoa needed an intervention for central nervous system (CNS) metastases. At 54 moths, the overall incidence for CNS metastases intervention was 22.8% versus 29.2%, respectively. Patients were treated until disease progression or an unacceptable toxicity.

The most common side effects, at any grade, included diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decrease, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment and muscle spasms. The most frequently reported of these side effects at grades 3 or 4 were diarrhea, nausea, vomiting, fatigue and decreased appetite. 83% of patients in the Nerlynx group experienced all-grade diarrhea compared to 66% in the Tykerb arm.

Nerlynx was previously approved in the United States for the extended adjuvant, supplementary, treatment of adult patients with early stage HER2-positive breast cancer after adjuvant trastuzumab, chemotherapy, based therapy. The current recommend dose of Nerlynx is 240mg taken orally once daily with food on days 1-21 of a 21-day cycle plus capecitabine (750 mg/m2 given orally twice daily) on days 1-14 of that 21-day cycle.

Check back later for what you need to know about this approval.