Puma secures FDA approval for sNDA for patients with breast cancer
Category: #health  By Saipriya Iyer  Date: 2020-02-28
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Puma secures FDA approval for sNDA for patients with breast cancer

Puma Biotechnology, Inc., a leading biopharma firm, recently announced that its supplemental New Drug Application (sNDA) for neratinib has received approval from the U.S. FDA. Combined with capecitabine, sNDA will treat adult patients suffering from metastatic or advanced HER2-positive breast cancer, specifically ones that have received more than two regimens based on anti-HER2 within the metastatic setting before.

Apparently, the approval of sNDA had been derived from the Phase III NALA trial results which are essentially neratinib plus capecitabine’s randomized and controlled trial in patients suffering from HER2-positive metastatic breast cancer, specifically for the ones who have gotten over two regimens based on anti-HER2 before.

Puma’s President and Chief Executive Officer, Alan H. Auerbach stated that despite a wide range of options for newer treatment available for patients suffering from HER2-positive breast cancer, it is noted that patients still require extra treatment options with the progress. The company believes that NERLYNX can possibly be the next therapeutic opportunity for such patients when based on the results of the company’s NALA data.

From Hillman Cancer Center located at University of Pittsburgh Medical Center and Magee-Women’ Hospital, Adam M. Brufsky, MD, Ph.D., commented that the approval by FDA was based on the data provided by the NALA trial that Brufsky had presented at ASCO in the previous year, showing that neratinib when combines with capecitabine provides a major improvement compared to the already available therapies across a thickly pretreated population.

It can also be an additional established role of NERLYNX for early breast cancer treatment. NERLYNX has been approved in the United States for an extended adjuvant treatment of adult patients suffering from early-stage HER2-positive breast cancer specifically following adjuvant therapy based upon trastuzumab. NERLYNX has received approval for several uses in the expanded adjuvant setting across Australia, Singapore, Argentina, Canada, and Hong Kong. 

 

Source Credit- https://investor.pumabiotechnology.com/news-releases/news-details/2020/Puma-Biotechnology-Receives-US-FDA-Approval-of-Supplemental-New-Drug-Application-for-Neratinib-to-Treat-HER2-Positive-Metastatic-Breast-Cancer/default.aspx



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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