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Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: yahoo.com Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor in gBRCA-mutated advanced breast cancer Pfizer Inc. (PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase …

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CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: apnews.com CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the …

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Approval decision delay seen as positive for Karyopharm

In Clinical Trials by Barbara Jacoby

By: Andrew Dunn From: biopharmadive.com Dive Brief: The Food and Drug Administration pushed back the deadline for an approval decision by three months for Karyopharm Therapeutics’ experimental cancer drug — and investors celebrated the delay. The drugmaker gave the agency additional clinical information on selinexor’s accelerated approval application as a late-line treatment for relapsed refractory multiple myeloma, leading the FDA …

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Intraoperative radiotherapy viable for certain patients with breast cancer

In Clinical Trials by Barbara Jacoby

By: Jennifer Southall From: healio.com Intraoperative radiotherapy remains a viable option for patients with low-risk breast cancer, according to a presenter at Miami Breast Cancer Conference. “Intraoperative radiotherapy has been used for at least 10 to 15 years and, in appropriately selected patients, published results of the treatment are quite good,” Frank A. Vicini, MD, FACR, FABS, FASTRO, radiation oncologist …

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Lilly’s CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Global, randomized, placebo-controlled study confirms CYRAMZA, in combination with erlotinib, significantly delayed disease progression in previously untreated patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations Global regulatory submissions to be initiated this year  Second positive Phase 3 study of CYRAMZA in metastatic non-small cell lung cancer Eli Lilly and Company (NYSE: LLY) today …

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Inovio Pharma (INO) Commences REVEAL 2 Global Phase 3 Clinical Study for the Treatment of HPV-Related Cervical Pre-cancer

In Clinical Trials by Barbara Jacoby

From: streetinsider.com Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the initiation and opening of sites to enroll the second portion of the company’s Phase 3 program for VGX-3100, Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV). The study, named REVEAL 2, is the company’s confirmatory stage Phase 3 clinical study and is designed to evaluate the …

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Margetuximab Improves Survival as HER+ Breast Cancer Treatment in Phase 3 Trial

In Clinical Trials by Barbara Jacoby

By: Jennifer Barrett From: specialtypharmacytimes.com Margetuximab, an investigational monoclonal antibody, improved progression-free survival (PFS) when used in combination with chemotherapy in patients with human epidermal growth factor receptor 2- (HER2) positive metastatic breast cancer, according to new data from a pivotal phase 3 trial. The SOPHIA study, which enrolled 536 patients, evaluated margetuximab in combination with chemotherapy compared with trastuzumab …

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Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.1 Men are considered hormone …

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Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer

In Clinical Trials by Barbara Jacoby

From: thelancet.com A randomised, non-inferiority, open-label, phase 3 trial Background To our knowledge, no randomised study has compared postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy in patients with breast cancer. This study aimed to determine whether a 3-week schedule of postmastectomy hypofractionated radiotherapy is as efficacious and safe as a 5-week schedule of conventional fractionated radiotherapy. Methods This randomised, non-inferiority, …

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OncoQuest Lays the Groundwork for Commencement of Phase 3 Study in Frontline Ovarian Cancer

In Clinical Trials by Barbara Jacoby

Source: OncoQuest, Inc. From: prnewswire.com OncoQuest Inc., a privately held, cancer immunotherapy company, has retained the services of IQVIA, a company formed through the merger of IMS Health and Quintiles, to manage OncoQuest’s planned Phase 3 clinical study in frontline ovarian cancer with the company’s lead product candidate, oregovomab, an anti-CA-125 antibody. OncoQuest will collaborate with IQVIA, a leading global …