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Puma Biotech's sNDA for Nerlynx Combo Gets FDA Acceptance

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Puma Biotechnology, Inc. (PBYI - Free Report) announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) of Nerlynx (neratinib). The sNDA is seeking approval of Nerlynx in combination with Roche’s (RHHBY - Free Report) Xeloda (capecitabine) to treat HER2-positive metastatic breast cancer in patients who have failed two or more prior lines of treatments. The regulatory body will announce its decision on the sNDA on April, 2020.

The company stated that the FDA is not planning to hold an advisory committee meeting to discuss this application.

This sNDA was based on data from the phase III NALA study, which assessed the combination of Nerlynx + Xeloda compared to Xeloda plus Novartis’ (NVS - Free Report) Tykerb (lapatinib) in the above-mentioned advanced breast cancer patient population.

In July 2019, Puma Biotech had submitted the sNDA to the FDA for getting the Nerlynx combo approved for the given patient population.

Nerlynx is already approved for use 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.

Shares of Puma Biotech have plunged 41.6% so far this year, wider than the industry’s decrease of 2.4%.

Notably, Nerlynx is the only marketed product in Puma Biotech’s portfolio. The drug generated sales of $99.4 million in the first half of 2019, reflecting an increase of 14.5% year over year. If the company gets an approval to include the NALA study data on Nerlynx’s label, it will be eligible to treat a broader set of breast cancer population, which can drive sales higher for the drug.

Meanwhile, several other studies 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 cancers including NSCLC and other tumor types that over-express or have a mutation in HER2.

In April this year, Puma Biotech added two cohorts to the phase II SUMMIT basket study on Nerlynx, which is presently being conducted for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutations. The company 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 Amgen Inc. (AMGN - Free Report) ,which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings estimates have been revised 2.9% upward for 2019 and 4.3% for 2020 over the past 60 days. The stock has inched up 0.6% year to date.

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