U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML)
“As part of the preparations for continued clinical development of vididencel in AML, we continue to strengthen the program in all product-relevant aspects, including on the regulatory front,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus. “The Fast Track Designation granted by the FDA adds substantial regulatory value to the vididencel program in […]
MAA submitted to the EMA for Approval of Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
“For patients with advanced UC, including FGFR-driven tumours, outcomes remain poor and treatment options are limited; therefore, there is a need for novel, targeted therapies,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. “We are excited by the prospect of bringing innovative, personalised approaches to market for patients as we work towards our […]
Calquence approved in China for chronic lymphocytic leukaemia
Professor Li Jianyong, Director of Haematology, People’s Hospital of Jiangsu Province, and Leader of China CLL Working Group, said: “Many people living with chronic lymphocytic leukaemia experience relapse and need additional treatment options to help manage their disease. I’m delighted that with this approval patients now have access to an established treatment that has already […]
KSQ Therapeutics and CTMC Announce Strategic Collaboration to Accelerate the Development of Novel Engineered Tumor Infiltrating Lymphocyte (eTIL) Therapies for the Treatment of Solid Tumors
“Our eTIL programs – which edit the SOCS1 and Regnase-1 genes – have the potential to be firstand best-in-class cell therapies for cancer treatment. As our eTIL programs move through INDenabling studies, our partnership with CTMC will have us ready to manufacture KSQ-001EX and KSQ-004EX for clinical studies,” said Qasim Rizvi, Chief Executive Officer of […]
Portage Biotech announces collaboration with Merck to evaluate two next-generation adenosine antagonists in combination with Keytruda® in solid tumors
“We are excited to initiate another collaboration with longstanding immunotherapy leader, Merck, to further explore the potential benefits of combining checkpoint blockade with PORT-6 and PORT-7,” said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. “Our suite of potentially best-in-class adenosine antagonists are designed to act on multiple immune cell types for potentially more […]
First Patient Dosed in Phase 1/2 Trial of BEAM-201 in Relapsed, Refractory T-ALL/T-LL
“As the first patient dosed with a Beam therapeutic candidate and the first patient in the U.S. to receive a base editing therapeutic, this represents a major milestone for the company, the scientists that made this possible, and the patients we hope to serve,” said John Evans, chief executive officer of Beam. “We believe that […]
TIVDAK® (tisotumab vedotin-tftv) Met its Primary Endpoint of Improved OS in Patients with Recurrent or Metastatic Cervical Cancer Compared to Chemotherapy
“TIVDAK is the only U.S. Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy,” said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen. “Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone […]
Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Improvement in PFS for RYBREVANT® (amivantamab-vmjw) + Chemo +/- Lazertinib vs chemo Alone in Patients with EGFR-Mutated NSCLC after Disease Progression on Osimertinib
“MARIPOSA-2 provides the first Phase 3 study data of RYBREVANT-based regimens in the broader EGFR-mutated non-small cell lung cancer population,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “The study builds on the significant innovation of RYBREVANT, a first-in-class bispecific antibody targeting two major oncogenic driver pathways, with […]
Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission announced
“We are pleased with the outcome of the pre-BLA meeting for EB-101 and believe that we have aligned with the FDA on what is needed for our upcoming BLA submission,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are focused on gathering and packaging the existing data over the coming weeks to meet the […]
ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers
“ENHERTU is the first HER2 directed therapy to demonstrate a potential benefit across a series of difficultto-treat cancers and these designations are recognition of the continued potential of this innovative medicine,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain committed to exploring additional opportunities for ENHERTU in these tumor types with the […]
Tecentriq subcutaneous (SC) is approved in Great Britain for all indications of IV Tecentriq, offering a faster, more convenient option to receive treatment
“Cancer immunotherapy has transformed the way we treat cancer. Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are working with […]
European Commission Approves KEYTRUDA + Trastuzumab and Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1
“Patients in the EU diagnosed with HER2-positive advanced gastric cancer face an aggressive disease associated with a poor prognosis, underscoring the need for additional first-line treatment options for these patients,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “With today’s approval of KEYTRUDA, we’re proud that patients whose tumors express PD-L1 […]
FAILED TRIAL: Ph 3 INNOVATE-3 trial of TTFields + paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of OS
“Recurrent ovarian cancer is a particularly aggressive cancer and options for patients diagnosed with platinum-resistance remain extremely limited,” said Ignace Vergote, MD, PhD, Principal Investigator and Chairman of the Belgium and Luxembourg Gynaecological Oncology Group and Professor at the Catholic University of Leuven, Belgium. “We are committed to continuing research with TTFields and exploring innovative […]
Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors Announced
“As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers,” said Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis. “We are grateful […]
FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
“The FDA’s granting of a Priority Review designation reinforces the need to bring new treatment options for patients with high-risk biochemical recurrent nmCSPC,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and Development Officer, Executive Vice President, Pfizer. “We believe the EMBARK data demonstrate the potential of XTANDI, if approved, to help patients earlier in […]
sBLA submitted to FDA for RYBREVANT® (amivantamab-vmjw) + Chemotherapy for 1LTreatment of Patients with EGFR Exon 20 Insertion Mutation-Positive mNSCLC
“PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results. This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid […]
Lack of ethnic diversity in Alzheimer’s disease clinical trials – how patients of color get side-lined.
Under-representation of people of color in clinical trials is a long-standing problem in medical research with far-reaching consequences on research outcomes and equity towards access to treatments. Clinical trials on the newly approved Alzheimer’s disease (AD) drug, Leqembi and Eli Lilly’s Donanemab, currently awaiting FDA’s decision, have both been criticized (1) for having less diverse […]
CARsgen Collaborates with Moderna to Evaluate CT041 in Combination with an mRNA Cancer Vaccine
“CT041 is the most advanced solid tumor CAR-T in development (pivotal phase II) and continues to show promise in treating gastric and pancreatic cancers. In our quest to make cancer curable, we are continuously exploring multiple modalities to eradicate tumors. Attacking tumors with CAR T-cell therapy in combination with a cancer vaccine could potentially provide […]
Verastem Oncology Enters Discovery and Development Collaboration with GenFleet Therapeutics to Advance New Programs Targeting RAS Pathway-Driven Cancers
“With the aim of bringing needed therapies to patients where there is high unmet medical need, we are looking forward to working with GenFleet on this important discovery and development collaboration,” said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. “This synergistic collaboration augments our research and development pipeline in alignment with our […]
IDMC Recommends Galinpepimut-S REGAL Trial to Continue Without any Modifications
“At its most recent meeting, we were pleased that the IDMC positively commented on the high level of study integrity and conduct, as well as the rate of enrollment to date. We look forward to the anticipated completion of enrollment in Q4, as well as the subsequent interim analysis, both significant milestones for our GPS […]
First participant of cohort 3 in the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in mCRPC treated at the highest dose level of 12GBq
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “Results from cohort 2 are incredibly exciting and we look forward to seeing data from the increased dosing of 12GBq as well as discover the potential positive effects of multi-dosing on prostate cancer patients.
Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated mCRPC
Mototsugu Oya, Professor and Chairman, Department of Urology, Keio University School of Medicine, Japan, said: “The PROpel trial showed that the combination of Lynparza plus abiraterone delivered clinically meaningful improvements in outcomes for patients with BRCA-mutated metastatic castration-resistant prostate cancer. With this approval, patients in Japan will now have the opportunity to benefit from this […]
Day One Announces VRK1 License Agreement and Research Collaboration with Sprint Bioscience
“This collaboration is an important continuation of measured portfolio development at Day One, which focuses on targeted therapies for children and adults with cancer in need of novel treatment approaches,” said Dr. Samuel Blackman, co-founder and head of research and development, Day One. “We look forward to collaborating with Sprint Bioscience, who has strong discovery […]
Two programmes evaluating CD47-blocking fusion protein evorpacept for patients with haematologic malignancies discontinued
“Based on the initial results of ASPEN-02 and the close connection between the mechanism of action with azacitidine in MDS and acute myeloid leukemia (“AML”), the Company will also terminate the ASPEN-05 program in AML and will not initiate a Phase 1b dose optimization clinical evaluation of evorpacept in combination with azacitidine and venetoclax. Based […]
Partial Clinical Hold Lifted on iMMagine-1 Phase 2 Clinical Program
“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “During the review process, we updated our trial protocol, and were pleased that FDA allowed for expanded bridging therapies, which better aligns our protocol […]
Phase 3 Trial of TUKYSA + ado-trastuzumab emtansine Meets Primary Endpoint of PFS in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer
“We are encouraged by these results for TUKYSA in combination with Kadcyla®in metastatic HER2-positive breast cancer, including in patients with brain metastases,” said Roger Dansey, President of Research and Development and Chief Medical Officer at Seagen. “We plan to present the HER2CLIMB-02 data at an upcoming medical meeting and discuss the results with the FDA.”
WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of PFS in Certain Previously Treated Patients With Advanced RCC
“Patients with advanced RCC face low survival rates, and for those whose cancer progresses following PD-1/L1 and VEGF-TKI therapies, there is a need for new treatment options that can reduce their risk of disease progression or death,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. […]
Odronextamab Receives EMA Filing Acceptance for Treatment of R/R FL and DLBCL
“Regeneron Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation […]
FDA Filing Acceptance and Priority Review for TIBSOVO in the Treatment of IDH1-mutated R/R Myelodysplastic Syndromes (MDS) announced
“Servier continues to drive our leadership in the scientific innovation behind targeted mutant IDH inhibition, transforming the treatment landscape for thousands of patients living with difficult and hard-to-treat cancers,” said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. “This filing acceptance and Priority Review for […]
LREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma
“ELREXFIO reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma,” said Angela Hwang, Chief Commercial Officer and […]
