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Puma Biotech Submits sNDA for Breast Cancer Drug Nerlynx

Zacks Equity Research

Puma Biotechnology, Inc. PBYI announced that it has submitted a supplemental new drug application (sNDA) to the FDA for the approval of Nerlynx (neratinib) in combination with Roche’s RHHBY Xeloda (capecitabine) to treat third-line HER2-positive metastatic breast cancer.

The drug is already approved as an extended adjuvant treatment of HER2-positive early stage breast cancer in adult patients, previously treated with Roche’s Herceptin-based adjuvant therapy. The drug was approved in Europe last September for the given indication.

The sNDA was based on data from the phase III NALA study, which assessed the combination of Nerlynx + Xeloda as compared to Xeloda plus Novartis’ NVS Tykerb (lapatinib) for treating patients with HER2-positive metastatic breast cancer, who have failed two or more prior lines of treatments. The co-primary endpoints of the study were centrally confirmed progression free survival (PFS) and overall survival (OS).

Outcomes from this program showed that treatment with the Nerlynx combo led to a statistically significant improvement in centrally confirmed PFS as compared to the combination of Xeloda plus Tykerb. Moreover, the median OS was 21 months for patients treated with the combo of Nerlynx + Xeloda as compared to the median OS of 18.7 months for patients having received the combo of Xeloda plus Tykerb. Notably, last December, Puma Biotech announced positive top-line results from the NALA study.

Shares of Puma Biotech have dropped 37.1% so far this year versus the industry’s rise of 5.3%.


Puma Biotech’s only marketed product, Nerlynx, generated sales of $45.6 million in the first quarter of 2019, reflecting a decline of 25.4% on a sequential basis due to higher number of patients discontinuing treatment with Nerlynx.

If the company wins a nod to include the NALA analysis finding on Nerlynx’s label, it will then be eligible to treat a broader breast cancer population, which can drive sales higher.

Several further probes on Nerlynx targeting different types of breast cancer subject-compositions and in earlier-line settings are currently underway.

Apart from the HER2-positive breast cancer indication, the company believes that Nerlynx holds great potential for the treatment of several other cancers including NSCLC and other tumor types that over-express or have a mutation in HER2.

Earlier this April, Puma Biotech added two cohorts to the phase II SUMMIT basket study on Nerlynx, which is currently being conducted for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutations. Puma Biotech plans to report data from this SUMMIT study in the second half of 2019 and expects to meet the FDA authorities to discuss the regulatory strategy for the same later in the ongoing year.

Zacks Rank & Key Pick

Puma Biotech currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Repligen Corp. RGEN, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings estimates have been revised 9.4% upward for 2019 and 9.8% for 2020 over the past 60 days. The stock has soared 63.2% year to date.

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