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Puma Biotech's (PBYI) Nerlynx Aids Growth Despite Competition

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On Mar 6, we issued an updated research report on Puma Biotechnology, Inc. (PBYI - Free Report) . The company’s top line mainly comprises sales of its sole marketed product, Nerlynx.

Nerlynx is approved in several countries including the United States and Europe as an extended adjuvant treatment of HER2-positive early-stage breast cancer in adult patients, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy. The drug was launched in the United States during July 2017 and across other countries thereafter.

Nerlynx generated sales of $211.6 million in 2019, up 5.5% year over year.

Notably, in February 2020, the FDA approved Nerlynx in combination with Roche’s Xeloda to treat third-line HER2-positive metastatic breast cancer based on data from the phase III NALA study. A decision from the regulatory agency was expected in April this year. Hence, this approval comes almost two months ahead of the scheduled date.

The approval to include the NALA study data in Nerlynx’s label should help address a broader breast cancer population, which can drive the drug’s sales higher in the future.

Several studies on Nerlynx targeting different types of breast cancer patient populations and in earlier-line settings are currently underway.

In October 2019, the FDA approved a labeling supplement for Nerlynx to include safety information based on interim results from the phase II CONTROL study, which evaluated the antidiarrheal prophylaxis or dose escalation in the reduction of Nerlynx-associated diarrhea.

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

A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers.

However, Puma Biotech has no approved product in its portfolio other than Nerlynx at the moment. Therefore, due to lack of a strong pipeline, the company is totally dependent on Nerlynx for growth. As a result, any kind of negative development or a regulatory setback could affect the company’s prospects in the long run. Stiff competition from other established drugs, such as Lilly’s (LLY - Free Report) Verzenio and Novartis' (NVS - Free Report) Kisqali among others is another matter of concern.

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