FDA Panel Backs Novel Anti-HER2 Drug for Breast Cancer

Excerpt:

“Another potential drug for HER2-positive breast cancer received strong numeric support from an FDA advisory committee, tempered by reservations about a broad indication, modest clinical benefit, and toxicity issues.

“By a 12-4 vote, the Oncologic Drugs Advisory Committee (ODAC) supported FDA approval of the dual HER2/EGFR inhibitor neratinib for early HER2-positive breast cancer that relapses after trastuzumab (Herceptin) maintenance therapy.”

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Can Less Costly 9-Week Trastuzumab Match Efficacy of 12-Month Regimen?

Excerpt:

“A cost-effectiveness analysis found that 9 weeks of trastuzumab therapy is better than the more standard 12 months in patients with HER2-positive breast cancer, without loss of clinical efficacy. The analysis is limited, though, by the need to combine various trials rather than any head-to-head comparisons.

“Trastuzumab has been shown to significantly improve survival in women with HER2-positive disease. ‘The budget impact of trastuzumab is high, mostly due to the drug’s high cost, and the most serious adverse effect observed is cardiac dysfunction,’ wrote study authors led by Caroline Clarke, PhD, of University College London in the United Kingdom. Though 12 months is considered the standard duration of therapy, some studies have also found similar results with only 9 or 10 weeks of trastuzumab.”

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Dual HER2-Blockade Plus AI Shows Promise in HER2+/ER+ Breast Cancer

Excerpt:

“Data from the phase II PERTAIN trial presented late last year at the 2016 San Antonio Breast Cancer Symposium (SABCS) showed that adding an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) extended progression-free survival (PFS) by over 3 months versus trastuzumab plus an AI in patients with HER2-positive, HR-positive locally advanced or metastatic breast cancer.

“The median PFS was 18.89 months with the pertuzumab triplet compared with 15.80 months for trastuzumab and an AI alone (HR, 0.65; 95% CI, 0.48-0.89; P = .007). The objective response rates were 63.3% versus 55.7%, respectively.”

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Three-Drug Breast Cancer Regimen Slows Progression

Excerpt:

“Adding a drug to a standard regimen for hormone receptor (HR)-positive and HER2-positive breast cancer improved progression-free survival, a researcher said here.

“In a Phase II randomized trial, investigators compared an aromatase inhibitor (AI) combined with pertuzumab (Perjeta) and trastuzumab (Herceptin) versus an AI just with trastuzumab in women with locally advanced or metastatic breast cancer, Grazia Arpino, MD, PhD, of the University of Naples Federico II in Italy, reported at a general session at the San Antonio Breast Cancer Symposium.

“The three-drug combination led to a median of 18.89 months without progression, compared with 15.8 months for the two drugs.”

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Hormonal Therapy Effectively Added to Dual HER2-Blockade in Phase II PERTAIN Study

Excerpt:

“The addition of an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) improved progression-free survival (PFS) by 3.09 months, when compared with trastuzumab plus an AI, according to findings from the phase II PERTAIN trial presented at the 2016 San Antonio Breast Cancer Symposium.

“In the ongoing, open-label study, the median PFS was 18.89 months with the pertuzumab combination compared with 15.80 months for trastuzumab and an AI alone. Furthermore, there was a 35% reduction in the risk of progression or death with the addition of pertuzumab (HR, 0.65; 95% CI, 0.48-0.89; P = .007).”

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A Breast Cancer Drug That Gets In The Brain? Cascadian Sees A Way Forward

Excerpt:

“Breast cancer patients sometimes end up dying when their tumors spread all the way to the brain. Some very good drugs already exist for patients with breast cancer, especially ones with tumors that overexpress the HER2 marker, but that success has raised a new question: Can drugmakers take another step, and fight those deadly brain metastases that get people in the end?

“Seattle-based Cascadian Therapeutics is testing that idea this week with researchers gathered at the San Antonio Breast Cancer Symposium. Cascadian is reporting today that patients who got conventional capecitabine and trastuzumab, plus an experimental small-molecule drug, tucatinib (aka ONT-380), lived a median of 7.8 months without their tumors getting worse. About 61% of patients on that triple-drug combo saw tumors shrink. It’s an impressive result, given that these patients were especially ill when they enrolled in the study, having already received a median of three prior rounds of HER2-targeted therapy. The data are also holding up over time: a snapshot of the data from June showed patients living a median of 6.3 months without their tumors spreading.”

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Study Findings Provide Latest Data on Neoadjuvant HER2+ Breast Cancer Treatment

Excerpt:

“Results from the KRISTINE and NSABP B-41 trials provided the latest data on the use of pertuzumab (Perjeta), trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), and lapatinib (Tykerb) for the neoadjuvant treatment of patients with HER2-positive breast cancer.

“In a lecture at the 2016 ASCO Annual Meeting, Stephen K. Chia, MD, an assistant professor in the division of Medical Oncology at the University of British Columbia, highlighted the key findings from these trials and their implications for the treatment of HER2+ breast cancer.”

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Expert Discusses Latest Data in Neoadjuvant HER2+ Breast Cancer

Excerpt:

“Results from the KRISTINE and NSABP B-41 trials presented at the 2016 ASCO Annual Meeting provided the latest data on the use of pertuzumab (Perjeta), trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), and lapatinib (Tykerb) for the neoadjuvant treatment of patients with HER2-positive breast cancer.

“In a lecture at the conference, Stephen K. Chia, MD, an assistant professor in the division of Medical Oncology at the University of British Columbia, highlighted the key findings from these trials and their implications for the treatment of HER2+ breast cancer.”

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NDA for Neratinib in HER2-Positive Breast Cancer Accepted by FDA

Excerpt:

“A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA, according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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