FDA Grants Fast Track Designation to ARX517 for the Treatment of mCRPC
“Receiving Fast Track designation from the FDA reinforces Ambrx’s belief in ARX517 as a potential novel treatment for mCRPC and underscores the urgent need for improved treatment options for patients at this advanced stage of prostate cancer,” said Sandra Aung, Ph.D., Chief Clinical Officer of Ambrx.
Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer
“Completion of the interim analysis with the DMC’s recommendation to continue PANOVA-3 to completion marks another important step in pursuit of our mission to treat patients with difficult solid tumors of the abdomen,” said Asaf Danziger, Novocure’s Chief Executive Officer. “I would like to express my thanks to our patients and investigators. We look forward […]
VANFLYTA First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML
“The approval of VANFLYTA represents a significant advancement for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which is one of the most aggressive and difficult-to-treat subtypes,” said Harry P. Erba, MD, PhD, Professor of Medicine, Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke Cancer Institute. “In the QuANTUM-First trial, […]
DRI Healthcare Trust Announces Acquisition of an Additional Royalty Interest in the Worldwide Sales of VONJO® (pacritinib)
“VONJO has addressed a significant unmet need in cytopenic MF patients and has seen an incredible uptake in its first year on the market,” said Behzad Khosrowshahi, Chief Executive Officer of the Trust. “We are excited to purchase a second royalty on this long duration, high-quality asset. This is the second royalty acquisition our team […]
NANOBIOTIX Announces License Agreement for Worldwide Co-development and Commercialization of Radioenhancer NBTXR3
“As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization […]
Initiation of Randomized Controlled Part B of the DeFianCe Study of DKN-01 in Colorectal Cancer Patients Announced
“Part A of the DeFianCe study enrolled an aggressive heterogenous population of second-line CRC patients representative of the second-line population that we see in the clinic who have poor outcomes on standard of care drugs and are in need of new therapies,” said Zev Wainberg, MD, Professor Medicine at UCLA and co-director of the UCLA […]
Enrollment in Phase 1/2 Study Discontinued; Development of THE-630 in Patients with GIST Terminated
“We are disappointed that we will not be able to achieve the target exposure for pan-variant inhibition with THE-630, as we continue to believe a therapy with potent activity against all major classes of activating and resistance mutations in KIT has the potential to confer significant clinical benefit, given the unmet need in GIST,” said […]
Opdivo + Chemo Shows OS & PFS Benefit for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial
“Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer. Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survivalin patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of […]
Positive data update provided on best response to therapy with first complete response in GLORIA trial in GBM, bringing 50% of patients in expansion arm to complete or near-complete response
“We are very pleased to report this highly positive update from the expansion arm of our GLORIA clinical trial evaluating our lead asset NOX-A12 in combination with radiotherapy and bevacizumab in glioblastoma,” said Aram Mangasarian, CEO of TME Pharma. “It is very encouraging to see one patient achieve no detectable tumor and two patients coming […]
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC)
“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 […]
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 […]
