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Neoadjuvant Systemic Therapy Improves Eligibility for Breast-Conserving Surgery in TNBC

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com Neoadjuvant systemic therapy may enable patients with triple-negative breast cancer (TNBC) who are ineligible for breast conservation therapy (BCT) to become eligible, according to a prespecified secondary analysis of the results from the phase III BrighTNess trial. “Surgical results from the BrighTNess trial demonstrate that neoadjuvant chemotherapy makes breast conservation possible in half of patients …

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FDA Grants Priority Review to Olaparib Plus Bevacizumab as Frontline Maintenance in Ovarian Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of olaparib (Lynparza) and bevacizumab (Avastin) for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response (PR) to first-line platinum-based chemotherapy with bevacizumab.1 The designation is based on results from …

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Radiation’s Role Shifts in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jessica Hergert From: oncnursingnews.com The role of radiation therapy, specifically with elective nodal irradiation (ENI), has evolved over the past several years, said He James Zhu, MD, PhD, adding that the technique should be performed in patients with breast cancer on an individualized basis. “[We need to be] educated about the role of ENI through regional lymph nodes with …

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Ibrance given NICE green light in breast cancer

In Clinical Studies News by Barbara Jacoby

By: Anna Smith From: pharmatimes.com Pfizer has announced the National Institute for Health and Care Excellence (NICE) approval of Ibrance (palbociclib), following a final guidance from the organisation. The potentially life-extending drug will now be available for patients with hormone receptor-positive, hormone receptor-positive (HER2)-negative, advanced breast cancer, who have already had endocrine therapy. The med, which will be available on …

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CDK Inhibitors with Endocrine Therapy Show Survival Benefit in Patients with Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Conor Killmurray From: curetoday.com Adding CDK 4/6 inhibitors to endocrine therapy for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer showed a survival benefit despite patients having differences in their tumors, according to a study published in Lancet Oncology. “To our knowledge, this is the first comprehensive pooled analysis of all marketed CDKIs (CDK 4/6 inhibitors) to …

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John Theurer Cancer Center Investigators Report Effectiveness of New Treatment for Refractory Multiple Myeloma

In Clinical Studies News by Barbara Jacoby

From: PR Newswire Triple-drug regimen shown to be superior to conventional treatment in major multicenter study presented at American Society of Hematology annual meeting  Investigators at John Theurer Cancer Center at Hackensack University Medical Center in New Jersey were part of the CANDOR global phase III clinical trial for patients with refractory (persistent) multiple myeloma. The study was selected as the …

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Celgene’s CC-486 positioned to become standard maintenance therapy in acute myeloid leukemia

In Clinical Studies News by Barbara Jacoby

Source: Global Data From: prnewswire.com Celgene plans to pursue a new drug application (NDA) in Q1 2020 for its formulation of oral azacitidine (CC-486) after data from the Phase III QUAZAR AML-001 trial showed that maintenance therapy can prolong the overall survival (OS) of acure myeloid leukemia (AML) patients compared with placebo. As such, CC-486 is set to address a …

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Premier Health offers new ovarian cancer clinical trial

In Clinical Studies News by Barbara Jacoby

From: dailycall.com Premier Health is the first health system in the United States to offer a new Phase III study for women who have been newly diagnosed with Stage III or IV BRCA negative ovarian cancer. This clinical trial, KEYLYNK-001, examines how the addition of a cancer immunotherapy drug, Keytruda, and an oral prescription medication known as a PARP inhibitor, …

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AstraZeneca’s Lynparza Gets FDA Nod for Pancreatic Cancer

In Clinical Studies News by Barbara Jacoby

Source: Zacks From: pharmavoice.com AstraZeneca AZN and Merck MRK announced that the FDA has approved their PARP inhibitor, Lynparza, as maintenance treatment for BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) in patients whose disease has progressed at least 16 weeks following first-line platinum-based chemotherapy regimen. Patients will be selected based on an FDA-approved companion diagnostic for Lynparza. With this approval, …

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FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer. The approval is based on findings from the phase III ARCHES trial, in which the median radiographic progression-free survival (rPFS) in men with metastatic castration-sensitive prostate cancer was not reached with enzalutamide plus …