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Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Knight Therapeutics From: finance.yahoo.com Knight Therapeutics Inc. (TSX: GUD), (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results …

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Neratinib Improve OS and CNS-Related Outcomes in Early-Stage HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Nichole Tucker From: targetedonc.com Treatment with neratinib demonstrated a modest overall survival benefit in patients with HER2-positive breast cancer compared with placebo, according to the long-term OS and central nervous system results from the phase 3 ExteNET trial Treatment with the irreversible pan-HER inhibitor neratinib (Nerlynx) demonstrated a modest overall survival (OS) benefit in patients with HER2-positive breast cancer …

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Celcuity Announces Breast Cancer Clinical Trial Collaboration with MD Anderson, Novartis, and Puma Biotechnology to Study New Drug Regimen

In Clinical Studies News by Barbara Jacoby

From: businesswire.com – Trial will evaluate the efficacy and safety of Novartis’ targeted therapy TABRECTA® and Puma’s NERLYNX® in patients with metastatic HER2-negative breast cancer selected by Celcuity’s CELsignia Multi-Pathway Activity Test – This is Celcuity’s second clinical trial to treat patients diagnosed with hyperactive HER2 and c-Met signaling breast cancers with matching targeted therapies – Five clinical trial collaborations …

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Neratinib Shows Numerical OS Improvement in Early Stage HER2+ Breast Cancer

In In The News by Barbara Jacoby

By: Kristi Rosa From: onclive.com Neratinib was shown to have a numerical overall survival benefit in addition to improvements in invasive disease-free survival and central nervous system recurrence in patients with HER2-positive, hormone receptor–positive, early stage breast cancer. Neratinib (Nerlynx) was shown to have a numerical overall survival (OS) benefit in addition to improvements in invasive disease-free survival (iDFS) and …

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Neratinib Shows Strong Benefit in Early-Stage, Metastatic HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com Neratinib’s (Nerlynx) greatest impact is in the early-stage setting in women with high-risk, HER2-positive breast cancer, said Joyce A. O’Shaughnessy, MD, who added that the agent can also be of benefit to patients with metastatic disease. “The ExteNET data [provide compelling evidence] that giving 1 year of neratinib along with endocrine therapy [in the extended …

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Homing in on Targeted Treatment Strategies in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com The fields of early-stage hormone receptor (HR)–positive and metastatic HER2-positive breast cancer have made great strides in recent years, said Neelima Denduluri, MD, and such progress could be attributed to the emergence of tailored treatment strategies and the use of HER2-directed agents, respectively. “We’re making great headway in [the treatment of patients with] breast cancer. …

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New Early Breast Cancer Drug Approved by Singapore Health Sciences Authority

In In The News by Barbara Jacoby

Source: Specialised Therapeutics Asia From: PR Newswire NERLYNX® (neratinib) now approved in Singapore for HER2+ breast cancer patients following adjuvant trastuzumab-based therapy NERLYNX is the first therapy in the Specialised Therapeutics’ portfolio approved in SE Asia Five-year follow up data show NERLYNX reduces risk of invasive disease recurrence by 42% in women with early-stage, HER2+/HR+ breast cancer and who commence …

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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 Studies News 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 …