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FDA grants orphan drug designation to Nerlynx for breast cancer brain metastases

In In The News by Barbara Jacoby

Source: FDA News From: healio.com The FDA has granted neratinib orphan drug designation for the treatment of patients with breast cancer and brain metastases, according to a press release from the drug’s manufacturer. Neratinib (Nerlynx, Puma Biotechnology) — an irreversible pan-HER tyrosine kinase inhibitor — is approved for the extended adjuvant treatment of adults with HER2-overexpressed breast cancer, following adjuvant …

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Key Trials Showcase the Utility of Neratinib in HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Caroline Seymour From: onclive.com Given the number of prophylactic interventions that are now available, counseling patients with early-stage HER2-positive breast cancer on the benefit of extended adjuvant therapy with neratinib (Nerlynx) or considering its use in those with central nervous system metastases could be beneficial, said Michel Velez, MD. “We know that neratinib has value in the extended adjuvant …

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Knight Therapeutics Announces Health Canada Has Approved NERLYNX ® for Early-Stage Breast Cancer

In In The News by Barbara Jacoby

From: globenewswire.com Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) for the extended adjuvant treatment of women with early-stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy1. Knight has the exclusive right to commercialize NERLYNX® in Canada under a license agreement …

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Phase III NALA Trial Results in Higher PFS With Neratinib Combo for HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Jason M. Broderick From: targetedonc.com Combining Neratinib (Nerlynx) with capecitabine (Xeloda) showed a 24% reduction in the risk of disease progression or death compared with lapatinib (Tykerb) plus capecitabine in patients with HER2-positive metastatic breast cancer who had previously received 2 lines of HER2-targeted therapy, according to the results of the phase III NALA trial presented at the 2019 …

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Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

In Clinical Trials by Barbara Jacoby

From: apnews.com Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago. Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients …

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Dr. Carcas on the Design and Findings of CONTROL Trial in HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Lauren Carcas, MD From: onclive.com Lauren Carcas, MD, medical oncologist, Miami Cancer Institute, Baptist Health South Florida, discusses the design of the CONTROL trial and her personal experience with prophylaxis interventions for women with early-stage HER2-positive breast cancer receiving neratinib (Nerlynx). The phase II CONTROL trial looked at how to control early-onset diarrhea within the first 2 cycles of …

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Breast cancer drug approved for Australia

In Clinical Trials by Barbara Jacoby

By: AAP From: 9news.com.au Kate Harper wants to be around to watch her two young twin sons grow up. That’s why, after grappling with the feeling of helplessness that came with being diagnosed with breast cancer, she made a commitment. “I said right from the start – and my husband’s in agreement as well – that we would attack everything …

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Cancer Research Highlight: Puma Biotech’s Basket Pays Off

In Clinical Trials by Barbara Jacoby

By: Zach Hartman From: seekingalpha.com Summary Puma Biotechnology is known almost exclusively as a breast cancer company. New basket study results may portend a move outside of there, but you have to think outside the box. How relevant are HER2 mutations, though? Puma Biotechnology (PBYI) has made its entire game up on the back of one drug, a “pan-HER” inhibitor …

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Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

In Clinical Trials by Barbara Jacoby

From: businesswire.com Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, is presenting updated results from a Phase II clinical trial of Puma’s drug neratinib at the 2018 San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. The presentation entitled, “The impact of neratinib with or without anti-diarrheal prophylaxis on health-related quality of life in …

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FDA approves new treatment to reduce the risk of breast cancer returning

In In The News by Barbara Jacoby

Source: U.S. Food and Drug Administration From: PR Newswire The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of …