Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 244

Posts Tagged ‘metastatic’

Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

Posted by fidest press agency su martedì, 31 dicembre 2019

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.The approval follows the recommendation by the U.S. FDA Oncologic Drugs Advisory Committee on Dec. 17 for LYNPARZA in this indication and was based on results from the pivotal Phase 3 POLO trial published in the New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.Results showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) where LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo (HR 0.53 [95% CI 0.35-0.81] p=0.0035).
Dave Fredrickson, executive vice president, head of the oncology business unit, AstraZeneca, said, “Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. LYNPARZA is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “LYNPARZA embodies Merck’s and AstraZeneca’s commitment to advance the treatment of challenging types of cancer, including metastatic pancreatic cancer. The expanded approval of LYNPARZA represents a significant milestone for patients and supports the value of germline BRCA testing in patients with this disease.” Dr. Hedy L. Kindler, co-principal investigator of the POLO trial and professor of medicine, University of Chicago Medicine, said, “Today’s approval of olaparib based on the POLO results gives clinicians an important first-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer.”
The Pancreatic Cancer Action Network (PanCAN) is a U.S.-based organization that supports and advocates on behalf of the patients, caregivers and communities affected by pancreatic cancer.LYNPARZA is currently approved in 65 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. It is approved in the U.S., the EU, Japan and several other countries as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 44 countries, including the U.S. and Japan, for gBRCAm, HER2-negative metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer.

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Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer

Posted by fidest press agency su sabato, 24 agosto 2019

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC).The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in February and published in The Journal of Clinical Oncology in July 2019. The study evaluated the efficacy and safety of XTANDI plus androgen deprivation therapy (ADT) versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival (rPFS) was met in the study.
Additionally, the submission is supported by data from ENZAMET, an Astellas-supported, investigator-sponsored Phase 3 research study led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney. The ENZAMET trial evaluated XTANDI plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with mHSPC to provide an active control. The results were presented during the Plenary Session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in June and simultaneously published in The New England Journal of Medicine. The primary endpoint of overall survival (OS) was met in the ENZAMET trial. The safety analyses of the ARCHES and ENZAMET trials appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC.

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Oncology Day

Posted by fidest press agency su sabato, 9 febbraio 2019

Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that management will present at the Guggenheim Healthcare Talks Idea Forum Oncology Day on Thursday, February 14, 2019 at 2:00 p.m. Eastern Time. The presentation will be webcast live and available for replay from Seattle Genetics’ website at http://www.seattlegenetics.com in the Investors section.
Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

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