ADCETRIS + Opdivo Combination Delivers 98% ORR and 93% CR in Patients with Early-Stage cHL
“With teens and young adults primarily impacted by Hodgkin lymphoma, our goal is to develop curative treatments that improve survival while also reducing toxicity,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at Massachusetts General Hospital and principal investigator of the trial. “The targeted agents of brentuximab vedotin and nivolumab […]
Additional ALLO-501/501A Phase 1 Data presented
“We believe these data provide strong support for the ability of our product candidates to induce durable complete remissions at a rate similar to approved autologous CD19 CAR T therapies,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. “The design and execution of our Phase 1 ALPHA/ALPHA 2 […]
FDA accepts sNDA for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
“PDAC is a devastating disease in need of additional treatment options. The FDA’s decision to accept the sNDA for this Onivyde-based regimen in treatment-naïve patients with metastatic disease represents an important milestone in the potential treatment of this complex form of cancer,” said Howard Mayer, Executive Vice President and Head of Research and Development at […]
FDA extends review period for momelotinib
GSK plc today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.
FDA gives go-ahead to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma
Pedro Lichtinger, Chairman and CEO of Starton Therapeutics commented, “Today’s announcement marks a significant development for Starton and patients in need of approved drugs and an improved quality of life, and we are excited to begin this critical program in transplant-ineligible patients with multiple myeloma. This study will provide initial evidence of the impact of […]
505(b)(2) NDA Approval granted from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable
“We believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation. By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors. This approval represents another high-value product for our growing injectables portfolio which […]
Six-Year OS Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma
“The ultimate goal in cancer research is to offer the best chance for a cure. Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them,” said David Epstein, Chief Executive Officer, Seagen. “The overall survival data are a major step forward in cancer research, and the transformative benefit […]
Partial Clinical Hold on UP-NEXT and UPGRADE-A Clinical Trials announced
“Patient safety is always at the forefront for us, and work is now underway to compile further analyses that may inform FDA,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “Additionally, with UPLIFT top-line data on the near-term horizon, we will soon have a much more complete assessment of both the efficacy […]
Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This Priority Review decision underscores the potential of capivasertib to extend the effectiveness of endocrine-based treatment approaches for patients with HR-positive breast cancer who experience tumour progression on, or resistance to these widely used therapies. We look forward to working with the FDA to bring this […]
FDA Approves Columvi for People With R/R DLBCL
“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this […]
mRNA-4157 (V940) + KEYTRUDA Combination Demonstrated a Statistically Significant DMFS Improvement in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA
“We are excited to be sharing these results with the oncology community and thrilled to see such an exceptional result in distant melanoma recurrence or death. Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore […]
Enhertu demonstrated clinically meaningful and durable responses in patients across multiple HER2-expressing advanced solid tumours
Funda Meric-Bernstam, MD, Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, US and principal investigator for the trial, said: “The DESTINY-PanTumor02 data showed encouraging and durable response rates across a broad range of HER2-expressing solid tumours where there are currently no approved HER2-targeted treatments. Based on […]
VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained PFS in CLL Patients
“Results from the CLL14 and MURANO studies demonstrate the long-term benefits of fixed-duration venetoclax combinations for patients living with CLL,” said Mariana Cota Stirner, M.D., Ph.D., vice president, hematology, AbbVie. “These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off […]
sBLA accepted for priority review for Jemperli + chemo For The Treatment of dMMR/MSI-H Primary Advanced Or Recurrent Endometrial Cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase III RUBY trial. Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, […]
FDA Accepts Application for KEYTRUDA Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer
“Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients with advanced or unresectable […]
NDA submitted to Japan’s MHLW for zolbetuximab in 1L CLDN18.2-positive HER2-neg gastric or gastroesophageal junction (mGEJ) adenocarcinoma patients
“Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission of a New Drug Application to Japan’s Ministry of Health, Labour and […]
NDA accepted for lurbinectedin in China
“PharmaMar (MSE:PHM) and Luye Pharma Group Ltd. have announced today that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the People’s Republic of China (China) for the treatment of adult patients with metastatic Small Cell Lung Cancer […]
PDUFA Date Extension for Nirogacestat NDA Announced
“We are confident that the comprehensive data from our Phase 3 DeFi trial demonstrate the transformative benefits that nirogacestat can bring to people with desmoid tumors, who currently do not have an approved therapy,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We remain committed to bringing this much needed therapy to patients and believe […]
FDA Has Lifted Clinical Hold on Ph 1 Study of FHD-286 in Relapsed and/or Refractory AML/MDS Patients
“With a focus on patient safety, we have worked with the FDA to resolve the clinical hold on FHD-286 in AML and MDS,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Clinical data suggest FHD-286 is a potent, broad-based differentiation therapeutic, and we believe it has significant combination potential as a treatment in […]
sBLA submitted to FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“We are focused on advancing CARVYKTI® in the treatment of multiple myeloma, including for patients with relapsed or refractory disease, where we hope to intervene earlier with the goal of transforming outcomes for patients,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We look forward to collaborating with […]
FDA Approves FoundationOne®LiquidCDx as a Companion Diagnostic for BRAFTOVI + Cetuximab combo to Identify Patients With BRAF V600E Alterations in mCRC
“Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this […]
CONFERENCE COVERAGE: 2023 European Hematology Association (EHA) Hybrid Congress
Samsung Biologics and Pfizer announce strategic collaboration for long-term manufacturing of biosimilars portfolio
“We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe,” said John Rim, President and CEO of Samsung Biologics. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had […]
Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility in Devens, Massachusetts
“The Devens facility integrates the latest state-of-the-art technology in the industry with top talent in the Boston area that will take us into the next phase of our cell therapy journey,” said Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb. “We are working diligently to increase our product capacity through […]
First Patient Dosed in Phase 1/2 Study of ROR1 targeting autologous CAR T, ONCT-808, in patients with relapsed or refractory aggressive B-cell lymphoma
“We are excited to announce the first patient, who had failed previous CD19 CAR T therapy, has been treated with ONCT-808,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma. It builds on our extensive clinical experience […]
Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors
“We are delighted to establish the global partnership with Eikon, whose leadership team has a well-documented track record of developing some of the world’s most therapeutically meaningful and commercially successful oncology medicines.” said Sui Xiong Cai, Ph.D., Chief Executive Officer of IMPACT Therapeutics. “As a company committed to develop innovative medicines globally, based on our […]
C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919
“We are excited to partner with Betta to develop CFT8919, an orally bioavailable allosteric EGFR L858R degrader, with the potential to treat NSCLC patients with EGFR L858R mutations in Greater China and beyond,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “With their strong track record of developing and commercializing NSCLC therapies […]
Phase 2/3 Pivotal Study REFRaME-O1 to be initiated in Ovarian cancer patients
Anne Borgman, M.D., Sutro’s Chief Medical Officer said, “On the heels of these positive results, we are thrilled that REFRaME, our pivotal Phase 2/3 trial, is officially underway. From the clinical and nonclinical data gathered, we maintain our positive outlook that luvelta could potentially serve multiple additional indications where patients express FolRα.”
Positive Lead-In Data from Ongoing Ph 3 PEAK Trial of Bezuclastinib + Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) announced
“These data reinforce our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients,” said Andrew Robbins, President, and Chief Executive Officer at Cogent Biosciences. “We are pleased to demonstrate in a robust clinical dataset that the addition of bezuclastinib to sunitinib does not […]
Lynparza + Imfinzi reduced risk of disease progression or death by 37% vs. chemo + Avastin in ovarian cancer patients without tumour BRCA mutations in the DUO-O Ph 3 trial
Professor Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany, and principal investigator for the trial, said: “The primary aim of first-line treatment of patients with advanced ovarian cancer is long-term control over the disease, but still too many patients progress quickly and face poor clinical outcomes today. Data from the […]
