Nerlynx Granted FDA’s Orphan Drug Status for Treating Breast Cancer with Brain Metastases

Nerlynx Granted FDA’s Orphan Drug Status for Treating Breast Cancer with Brain Metastases
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Puma Biotechnology’s Nerlynx (neratinib) for the treatment of HER2-positive breast cancer in women with brain metastases. Between 10 to 15% of people with metastatic breast cancer develop brain metastases. However, that number reaches up to 30% in women with advanced HER2-positive breast cancer. Orphan drug designation provides Puma with benefits, including financial incentives for therapy development and commercialization. It also provides U.S. market exclusivity for a period of seven years following the medication's approval, FDA support for clinical studies, and special fee exemptions and reductions. The designation is given to investigative treatments aimed at helping people with a rare disease, which means it affects fewer than 200,000 people in the U.S. “Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer,” Alan H. Auerbach, chairman, CEO, and president of Puma, said in a press release. Nerlynx was approved by the FDA in July 2017 as an extended,
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