Showing posts from January, 2021

Lilly and Merus NV Announce Collaboration to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY ), and Merus N.V. (NASDAQ: MRUS ), a clinical-stage oncology company developing multi-specific antibodies, today announced a research collaboration and exclusive license agreement that will leverage Merus' proprietary Biclonics® platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. Under the terms of the agreement, Merus will lead discovery and early stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development and commercialization activities. Merus will receive an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product,

US FDA approves Daiichi Sankyo & AstraZeneca’s Enhertu to treat locally advanced /metastatic HER2 positive gastric or gastroesophageal junction

Daiichi Sankyo Company, Limited and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.In the US, gastric cancer is more frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving five years. Approximately one in five gastric cancers is HER2 positive. “Patients with metastatic HER2 positive gastric cancer with progression following first-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression,” said Ronan Kelly, MD, MBA, director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas. “This approval represents the first time a HER2 directed medicine has demonstrated a significant impro

Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.1,2,3 Approximately 90% of ALCL cases in young people are ALK-positive.4,5,6 “We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL. XALKORI offers a meaningful new treatment option for young patients with relapsed or refractory ALK-positive ALCL,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Gl

4baseCare and ACTREC-Tata Memorial Centre join hands for development of AI based clinical interpretation platform

4baseCare, an Illumina Accelerator backed Precision Oncology start-up and ACTREC (Advanced Centre for Treatment, Research and Education in Cancer) - Tata Memorial Centre have signed a collaboration agreement for an AI driven clinical interpretation platform, ClinOme. The collaboration aims at making an indigenous platform to generate data insights and simplified reports to guide oncologists with personalised treatment options for treating cancer patients. ClinOme is a Graphical User Interface (GUI) based automated tool developed by senior scientists & clinicians from ACTREC & Tata Memorial Hospital by Dr. Amit Dutt, Dr. Pratik Chandrani and Dr. Kumar Prabhash for analysis of raw NGS data followed by comprehensive clinical report generation. It automates quality check, primary, secondary and tertiary analysis of raw NGS data followed by report generation that can be easily comprehended by the clinicians. It provides easy to interpret categorization of genomic alterations alo

EMA validates Bristol Myers Squibb’s MAA for Opdivo as adjuvant treatment for esophageal or GEJ following chemoradiotherapy

Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo (nivolumab) as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. Validation of the application confirms that submission is complete, and the EMA’s centralized review process will begin. The application is based on results from the phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival (DFS) - its primary endpoint – in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous Opdivo studies. “The majority of esophageal cancer patients with localized disease who are treated with both chemotherapy and surgery do not achieve complete response