sNDA submitted to FDA for BRUKINSA in combination with obinutuzumab as a treatment for relapsed or refractory follicular lymphoma
“Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. We are therefore pleased that BRUKINSA is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the […]
European Commission approves fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
“As pioneers in the development of innovative T-cell-engaging bispecific antibodies, we are delighted that we can now offer Columvi as the first approved treatment of its kind to people in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are confident that thanks to its off-the-shelf availability, […]
Enhertu approved in China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Binghe Xu, MD, Director of the National Clinical Research Center for New Anticancer Drugs, Tenured Professor and Former Director, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, said: “Historically, breast cancer tumours with low levels of HER2 expression have been classified as HER2-negative and have not been […]
Caribou Biosciences Announces $25 Million Equity Investment from Pfizer
“We believe Pfizer’s investment in Caribou highlights the potential of our clinical programs and we are excited to establish this partnership with one of the world’s premier biopharmaceutical companies,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “We are actively advancing our allogeneic CAR-T cell therapy pipeline and look forward to providing updates […]
F-star Announces Strategic Collaboration and Licence Agreement with Takeda to Discover and Develop Next-Generation Multi-Specific Antibodies
Neil Brewis, Ph.D., Head of F-star Therapeutics and Chief Scientific Officer said: “We are delighted to expand our relationship with Takeda who shares our vision of developing pioneering multi-specific immunotherapies so more people with cancer can live longer with improved lives. This strategic collaboration leverages the capabilities of both companies by combining F-star’s clinically validated […]
FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID
“We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 […]
New Positive Interim Ph 3 Data Demonstrating RenovoGem™ Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer Announced
“Clinical practice has been waiting decades for a meaningful advancement in the standard of care for pancreatic cancer treatment, with less toxicity and better outcomes. The new data from the TIGeR-PaC interim results support that RenovoGem has the potential to more than double progression-free survival compared to systemic chemotherapy alone in this difficult-to-treat cancer, which […]
Datopotamab Deruxtecan Met Dual Primary Endpoint Of PFS In Patients With Advanced NSCLC in TROPION-Lung01 Phase 3 Trial
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first Phase III trial results from the datopotamab deruxtecan clinical programme provide […]
Paxalisib Receives Fast Track Designation From FDA For Treatment Of Solid Tumor Brain Mets Harboring PI3K Pathway Mutations In Combination With Radiation Therapy
“Brain metastases are rapidly emerging as a key pillar of paxalisib’s clinical development,” said Dr. John Friend, Chief Executive Officer of Kazia. “We have seen a high level of interest from clinicians in the emerging data from this patient population, and it is exciting to now have that interest complemented by FDA’s award of Fast […]
FDA Grants Priority Review for Zolbetuximab Biologics License Application
“Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer. While rare in the U.S., gastric cancer can be deadly when diagnosed in the late stages,” said Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas. “The FDA’s acceptance of the Biologics License Application filing and […]
NMPA Approves FUCASO, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma in China
Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, “Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There’s an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO®, as an innovative fully-human […]
European Commission Grants Conditional Marketing Authorization for LYTGOBI Tablets for the Treatment of Adults With Cholangiocarcinoma
“Today is an important day for current and future patients with CCA as well as the healthcare providers who treat them,” said Peter Foertig, MD, Vice President, Medical Affairs, Taiho Oncology Europe. “LYTGOBI is an oral molecularly targeted medication that may provide clinically meaningful outcomes for patients undergoing treatment for CCA.”
Mestag Therapeutics and VIB enter into an exclusive partnership in oncology
Susan Hill, PhD, Chief Executive Officer of Mestag Therapeutics, said, “We are delighted to partner with VIB, one of the premier research institutes in Europe and a leader in nanobody technology and cancer biology. This agreement further strengthens Mestag’s first-in-class pipeline and targets an exciting new area of fibroblast-immune cancer biology.”
K36 Therapeutics Announces $70 Million Series B Financing to Fund Clinical Proof of Concept of KTX-1001 for Treatment of Multiple Myeloma Patients with Genetic Translocation (4;14)
“We are committed to developing KTX-1001 for t(4;14) multiple myeloma patients, a large patient population with chronic disease who are relatively unresponsive to existing and emerging therapeutics,” said Terry Connolly, Ph.D., Chief Executive Officer of K36 Therapeutics. “We welcome our new investors who bring extensive expertise in cancer drug development as well as company building, […]
First patient dosed in Ph 2 MATISSE study in combination with durvalumab and chemotherapy in treatment-naïve patients with resectable early stage NSCLC
Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer at Innate Pharma “We are pleased to announce the dosing of a first patient in this Phase 2 study conducted in collaboration with our partner AstraZeneca. The study aims to assess the potential of combining our IPH5201 drug candidate with durvalumab as neoadjuvant treatment with chemotherapy and […]
Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer initiated
“In recent years, immune-oncology (I-O) therapy has made rapid advancements, particularly in the field of lung cancer, where it has emerged as the standard of care for first-line treatment of advanced NSCLC,” said Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences. “Regarding more aggressive SCLC, however, the progress in I-O therapy […]
FDA clears Roche’s Elecsys CSF diagnosis assays for Alzheimer’s disease
Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays received FDA’s 510(k) clearance (also called pre-market notification) for early and accurate diagnosis of Alzheimer’s disease (AD). This assay pair measures the ratio of two biomarkers of AD viz., tau (tTau) and beta-amyloid (Abeta42). It will hit the market in Q4 of 2023 […]
Imfinzi + Imjudo demonstrated sustained OS benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Ph 3 trial
Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, Pamplona, Spain and a lead investigator in the trial, said: “Historically, only seven per cent of patients with advanced liver cancer have survived five years, making the HIMALAYA long-term survival data especially meaningful. One in four […]
Datopotamab deruxtecan met dual primary endpoint of PFS in patients with advanced NSCLC in TROPION-Lung01 Phase III trial
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first Phase III trial results from the datopotamab deruxtecan clinical programme provide […]
U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer
“We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. “This is another exciting achievement in our REQORSA development program, which further validates REQORSA’s potential […]
Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer
“We believe the compelling clinical data for Zeno in NRG1+ cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential BLA submission,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Additionally, our intention to partner Zeno is a reflection of our strategy […]
NEOGAP acquires TCER Oncology AB, strengthening its position in personalised immunotherapy
“We are delighted to acquire the remaining shares in TCER Oncology and extend a warm welcome to Rolf Kiessling and Stina Wickström as valued shareholders in NEOGAP. This acquisition marks an important milestone, fortifying our standing in personalised immunotherapy. It allows us to expand our patent portfolio and pipeline of potential drug candidates while further […]
First Patient dosed in Ph 1 Study of Cancer Vaccine CVGBM for Surgically Resected Glioblastoma
“We are excited to enter the execution phase of our cancer vaccine development strategy with a study that is designed to establish proof-of-principle for our advanced second-generation mRNA backbone in oncology,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “We will use the study data to evaluate the ability of our second-generation mRNA backbone […]
First Patients Dosed in Ph 2 Liver Cancer Trial of TTI-101
“Enthusiasm for our HCC study continues to expand with recently presented clinical data demonstrating TTI-101 monotherapy has robust efficacy in heavily pretreated patients with HCC, published preclinical work highlighting TTI-101’s synergy with immunotherapy, and the FDA’s Fast-Track Designation for TTI-101 in HCC,” said Imran Alibhai, PhD, CEO of Tvardi Therapeutics. “This is the second of […]
Ongoing Double-Digit ORR observed for Single Agent Envafolimab in the ENVASARC Phase 2 Pivotal Trial
“We are pleased with the single agent activity of envafolimab that continues to generate a double-digit ORR, as well as the safety data showing envafolimab is well tolerated,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “We believe the current response rate indicates that we remain on track to achieve the primary endpoint of the […]
FAILED TRIAL: Ph 3 KEYNOTE-585 Trial in GEJ Adenocarcinoma didn’t meet primary endpoint of EFS
“While a statistically significant improvement in pathological complete response was observed in this study, we are disappointed that the KEYTRUDA regimen did not significantly improve event-free survival, a result that underscores the challenges in treating locally advanced resectable gastric cancer,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “Innovative research in […]
CHMP Positive Opinion for Trodelvy in Pre-Treated HR+/HER2- Metastatic Breast Cancer
“This positive opinion from the Committee confirms the clinical benefit and value of sacituzumab govitecan in pre-treated HR+/HER2- metastatic breast cancer and is a positive step toward bringing this treatment option to patients in Europe,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “Too many people living […]
FDA Orphan Drug Designation for ERAS-801 for the Treatment of Malignant Glioma
“GBM is an aggressive malignancy afflicting approximately 37,000 patients annually in the United States and Europe. Currently approved EGFR inhibitors are limited by insufficient CNS penetration to treat GBM and minimal activity against GBM-specific EGFR amplifications, mutations, and other molecular alterations, which contribute to high rates of relapse and a five-year survival rate below 10%,” […]
FDA Grants Full Approval For Blincyto To Treat MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
“We are pleased the FDA has granted full approval for BLINCYTO, the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy and the first to be FDA-approved for MRD in 2018,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Today’s full approval underscores the clinical benefit of BLINCYTO for people […]
TALZENNA in Combination with XTANDI Receives U.S. FDA Approval for adult patients with HRR-mutated mCRPC
“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy. Therefore, new first-line treatment options are needed to reduce the risk of disease progression or death. For patients with mCRPC harboring HRR genetic alterations, outcomes are even worse,” said Neeraj Agarwal, M.D., […]
