Puma Gets FDA Approval for Supplemental New Drug Application

Puma Biotechnology (NASDAQ:PBYI) has officially received acceptance from the US Food and Drug Administration (FDA) for its supplemental new drug application for neratinib in combination with capecitabine to treat HER2-positive metastatic breast cancer. 

In the press release issued on Wednesday (September 11), the company said the FDA’s action date for review will be sometime in late April 2020.

Neratinib was first approved by the regulatory agency in July 2017 for the extended adjuvant treatment of early HER2-positive breast cancer for patients that previously took a trastuzumab regimen. The treatment is currently marketed in the US under the name Nerlynx and is sold as tablets.

“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,” Alan H. Auerbach, CEO and president of Puma, said in the press release.

The supplemental new drug application comes following results of the company’s Phase 3 NALA trial of neratinib in combination with capecitabine versus Tykerb plus capecitabine in HER2-positive metastatic breast cancer patients. Approximately 620 patients participated in the randomized trial in clinics across North America, Europe, Asia-Pacific and South America.

HER2-positive breast cancer is the most aggressive form of the disease, and between 20 and 25 percent of breast cancer tumors have the HER-2 protein.

Wednesday’s announcement comes days after the company revealed that the FDA granted it orphan drug designation for the same drug to treat patients with breast cancer who have brain metastases.

“Receiving orphan drug designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer,” Auerbach said in that release.

According to a report from GlobalData, between the major markets of the US, France, Germany, Italy, Spain, the UK, Japan and China, the HER2-positive breast cancer sector will be worth US$9.89 billion by 2025 as more biosimilars come into the picture.

The report also says that HER2-positive breast cancer will enter a “new setting” thanks to Puma’s treatment, which could help fuel additional growth as more companies look to target the disease.

“Although the efficacy of HER2-targeted therapies substantially improves the life expectancy of patients with HER2-positive disease, it is by nature one of the most aggressive forms of breast cancer, with a poorer prognosis and worse outcomes than for patients with HER2-negative (and HR-positive) disease,” Max Bourgognon, then-healthcare analyst with GlobalData, said in the release.

Following Puma’s announcement on Wednesday, shares of the company dipped 4.88 percent to close the trading session at US$11.88. Year-to-date, the company’s share price has dipped 42.39 percent.

Based off five analyst ratings on TipRanks, Puma’s shares are ranked as a “moderate sell” with an average price target of US$16.60, high estimate of US$25 and low of US$9. The most recent analyst rating was given by Yigal Nochomovitz from Citigroup (NYSE:C), who reiterated a “hold” position on the company.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.