The U.S. Food and Drug Administration (FDA) has agreed to review Puma Biotechnology’s application seeking approval of Nerlynx (neratinib), in combination with capecitabine, to treat HER2-positive breast cancer patients with metastatic disease, the company has announced.
“The FDA’s acceptance of our sNDA marks another important regulatory milestone for my team,” Alan H. Auerbach, CEO and president of Puma, said in a news release.
“We look forward to working with the FDA during its review of this submission, which targets patients with HER2-positive metastatic breast cancer who have progressed on two or more prior treatments and who need additional treatment options,” he added.
Puma’s application is based on data from the NALA Phase 3 trial (NCT01808573), which showed that Nerlynx plus capecitabine (brand name Xeloda, generics also available) extended the time patients lived without their disease worsening, compared with a combination of capecitabine plus Tykerb (lapatinib), another therapy for HER2-positive breast cancer.
The NALA trial included 621 women with HER2-positive metastatic breast cancer who had received at least two HER2-targeted treatments in the metastatic setting.
Nerlynx also tended to extend overall survival, although this improvement showed no statistical significance — 24.0 vs. 22.2 months with Tykerb, at four years of study.
Consistent with prior Phase 2 findings — which showed that Nerlynx plus capecitabine shrank brain metastasis in nearly half of HER2-positive breast cancer with metastatic brain tumors — patients in the NALA trial required fewer brain metastasis interventions at 4.5 years when receiving Nerlynx (22.8%) compared with those taking Tykerb (29.2%).
The rate of treatment-related adverse events was similar between the two groups, but fewer patients on Nerlynx (10.9%) discontinued therapy due to such events than in the Tykerb group (14.5%).
Recently, the FDA granted the therapy orphan drug status for the treatment of women with HER2-positive breast cancer with brain metastases. The designation provides Puma with benefits, including FDA support for clinical studies, and special fee exemptions and reductions.
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