Daiichi Sankyo Company, Limited: Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer
Daiichi Sankyo Company, Limited
(hereafter, Daiichi Sankyo) and AstraZeneca s trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive.
1,2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.
(1) Agendia, Inc., a world leader in precision oncology for breast cancer, today announced that additional data from its groundbreaking MINDACT study will be highlighted in an oral presentation by Laura van t Veer, Ph.D., Co-founder and Chief Research Officer, at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020). These data highlight the ability of MammaPrint
, Agendia s 70-gene breast cancer recurrence assay, to further stratify patients with clinically low risk breast cancer which could impact physician-patient discussions and treatment planning.
MINDACT (?M?icroarray ?I?n ?N?ode-Negative and 1-3 node-positive ?D?isease may ?A?void Chemo?T?herapy), the Phase 3, prospective, randomized clinical trial supported by the European Organization for Research and Treatment of Cancer (EORTC), was designed to determine whether MammaPrint could be used to safely de-escalate patients with early stage breast cancer from chemotherapy without compromising their outcomes. Updated o
New Study Provides Personalized Breast Cancer Risk Information for Women with ATM Gene Mutations yahoo.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from yahoo.com Daily Mail and Mail on Sunday newspapers.
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Shares0 Outcomes4Me Inc.and Foundation Medicine Inc. reveals breast cancer patients are not offered genomic testing.
Genomic testing allows doctors to learn more about a tumor’s individual characteristics and ultimately provide the patient with more personalized treatment options.” said Osama Rahma, M.D., Co-Founder and Chief Medical Advisor of Outcomes4Me. “Test results can also expand patient access and eligibility for new and innovative treatments including clinical trials, and have been proven to help prolong a patient’s life. Although Medicare and most healthcare insurance companies cover 100% of the costs associated with genomic profile testing, the data shows that most advanced breast cancer patients don’t get their tumor profiled.”
Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer
SBLA Currently Under Review by the U.S. FDA for Full Marketing Approval in mTNBC Gilead Sciences, Inc. is presenting new data from the Phase 3 ASCENT trial of Trodelvy ® in metastatic triple-negative breast cancer at the 2020 San Antonio Breast Cancer Symposium being held virtually December 8-11, 2020. The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy … sBLA Currently Under Review by the U.S. FDA for Full Marketing Approval in mTNBC Gilead Sciences, Inc. (Nasdaq: GILD) is presenting new data from the Phase 3 ASCENT trial of Trodelvy