FDA clears IND application for anti-HLA-G CAR-T cell therapy IVS-3001
“The FDA clearance of the IND application for IVS-3001 represents an important milestone for Invectys and our colleagues at CTMC, and it is the result of years of commitment to developing a novel class of engineered CAR-T therapy,” said Praveen Tyle, Ph.D., CEO of Invectys. “We believe IVS-3001 therapy has the potential to significantly transform […]
FDA Approves Clinical Trial Application for BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma
Dr. Wen (Maxwell) Wang, Chief Executive Officer of IASO Bio, said, “The IND approval of CT103A in the U.S. is an important milestone of IASO Bio and a new starting point outside China. IASO Bio will accelerate its overseas clinical trials and the development and implementation of cellular immunotherapy drugs to benefit more patients globally.”
FDA Accepts sBLA for PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA for the 1L Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
“We look forward to working closely with the FDA as we seek potential accelerated approval for this combination in the hopes that it can be another treatment option for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of […]
Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer
Ken Takeshita, Global Head, R&D Daiichi Sankyo, said: “This positive CHMP opinion recognises the unmet need in the European Union for patients with HER2-low metastatic breast cancer. Currently, once patients with HR-positive disease progress on hormone therapy there are limited effective treatments, and few targeted options are available for patients with HR-negative disease. We look […]
FDA approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with R/R follicular lymphoma
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging […]
Zynlonta® (loncastuximab tesirine) approved in the EU for the treatment of R/R DLBCL
“We are delighted by the European Commission’s approval of Zynlonta” said Anders Ullman, Head of Research & Development and Medical Affairs, Chief Medical Officer at Sobi. “We look forward to making Zynlonta available as a new treatment option to patients in the EU impacted by diffuse large B-cell lymphoma, a debilitating disease in haematology.”
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer. This approval underscores our commitment to transform survival outcomes while addressing the high unmet need for new and improved treatments for patients […]
CAR T Cell Therapy Breyanzi Approved as R/R DLBCL 2L Therapy in Japan
Commenting on the approval, Makoto Sugita, Bristol Myers Squibb’s head of R&D in Japan, said, “We are very pleased that Breyanzi has been approved for use in the second-line treatment of relapsed or refractory LBCL, regardless of whether autologous hematopoietic stem-cell transplantation is intended. This approval is a major step forward for patients with refractory […]
FDA approved Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
“Patients with BCG-unresponsive NMIBC have historically had limited treatment options other than bladder removal surgery,” said Steven A. Boorjian, M.D., Carl Rosen Professor and Chair of the Department of Urology at Mayo Clinic, and lead investigator on the recent clinical trial of Adstiladrin. “The approval of Adstiladrin is therefore a significant advance in the current […]
Lynparza + abiraterone approved in the EU as 1st-line treatment for patients with mCRPC based on Ph 3 PROpel trial results
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Many patients with metastatic castration-resistant prostate cancer are only able to receive one line of active therapy, as the disease can progress quickly. Lynparza in combination with abiraterone has been shown to reduce the risk of disease progression by 34% versus the standard of care […]
Calquence approved in Japan for adults with treatment-naïve chronic lymphocytic leukaemia
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The approval of Calquence in Japan for those with treatment-naïve chronic lymphocytic leukaemia now offers more patients a next-generation Bruton’s tyrosine kinase inhibitor that has proven longer-term efficacy and tolerability compared to standards of care. With this approval, people living with chronic lymphocytic leukaemia in […]
Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Japan has one of the highest rates of diagnosis for liver and biliary tract cancers in the world, and lung cancer remains the country’s leading cause of cancer death. With these approvals for Imfinzi and Imjudo, patients in Japan can now be treated with novel […]
Enhertu approved in the EU for patients with previously treated HER2-positive advanced gastric cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Today’s important approval makes Enhertu the first HER2-directed medicine to be approved for gastric cancer in the European Union in more than a decade. Patients across the EU with advanced HER2-positive disease who have progressed following treatment in the first-line setting, may now have the […]
Conference Coverage: 64th American Society of Hematology (ASH) Annual Meeting 2022
Immix Biopharma in-licenses NXC-201 Demonstrating High CRR in Heavily Pre-Treated Multiple Myeloma (71% CR) and AL Amyloidosis (100% CR)
“We are thrilled to share that we have secured exclusive rights to NXC-201, a next generation BCMA CAR-T therapy whose 85% ORR and 71% CR rate in heavily pretreated multiple myeloma patients in the ongoing Phase 1 trial are compelling,” said Ilya Rachman, MD PhD, CEO of Immix Biopharma. “Additionally, encouraged by the 100% complete […]
Clovis Oncology Files For Chapter 11 Protection And Enters Bankruptcy With Agreement To Sell FAP-2286 to Novartis
Clovis Oncology, Inc. announced that it and certain of its subsidiaries (collectively, the “Debtors”) have voluntarily initiated a Chapter 11 proceeding in the United States Bankruptcy Court for the District of Delaware (“Bankruptcy Court”) and will seek to sell their assets through a court supervised sales process. The Debtors have filed various “first day” motions […]
Calidi Biotherapeutics Receives Funding from the California Institute for Regenerative Medicine (CIRM) to Advance SuperNova-1 and NeuroNova-2 Development Programs
“With limited treatment options and poor survival rates, there remains a significant unmet need for the development of effective treatment options for patients suffering from metastatic/unresectable melanoma, triple negative breast cancer, and advanced head and neck squamous cell carcinoma,” said Boris Minev, M.D., President, Medical and Scientific Affairs of Calidi Biotherapeutics and the principal investigator […]
Adagene and Roche to Evaluate SAFEbody® ADG126 in Combination with Standard-of-Care for 1L HCC
“We are excited to initiate this collaboration with Roche and explore the potential of ADG126 as a key component of a triplet combination for treating first-line liver cancer, along with an established standard-of-care doublet pioneered by Roche,” said Peter Luo, Ph.D., Co-founder and CEO of Adagene. “Given the longstanding safety challenges of combining multiple therapies […]
Safety Review Committee Approves to Proceed to Final Cohort in Acclaim-1 Ph 1 Dose Escalation Trial of REQORSA® + Tagrisso® in Advanced NSCLC
“The SRC’s recommendation to increase the dosing of REQORSA is further confirmation of its favorable safety profile and it enables us to advance Acclaim-1 into the final cohort of the Phase 1 dose escalation portion of the study,” said Mark Berger, M.D., Chief Medical Officer of Genprex. “We look forward to completing enrollment of this […]
mRNA-4157/V940 + KEYTRUDA® (pembrolizumab) Met Primary Efficacy Endpoint in Ph 2b KEYNOTE-942 Trial
“Today’s results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We will begin additional […]
Zolbetuximab Meets Primary Endpoint in Ph 3 GLOW Trial as 1L Treatment in Claudin 18.2 +ve HER2-neg Locally Advanced Unresectable or Metastatic GEJ Cancers
“Zolbetuximab has the potential to be an innovative therapeutic option for patients with locally advanced unresectable or metastatic gastric or GEJ cancer, a difficult disease for which treatment options are still limited,” said Ruihua Xu, MD, PhD, Primary Investigator for the GLOW study and Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer […]
Initial Data from the Ongoing Ph 2B VITALIZE Trial in Patients with r/r DLBCL announced
“The initial clinical data from the VITALIZE trial are encouraging and the accelerating recruitment in this study reflects a growing interest for this therapeutic combination in DLBCL,” said Dr. Matthew Matasar, Chief of Blood Disorders at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health, and primary investigator of the VITALIZE trial. He added: “We […]
80% ORR reported in Final Cohort of Ph 1 Single Agent Trial of Annamycin for the Treatment of AML
“Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic. We have continued to make significant progress across our clinical trial programs evaluating Annamycin in STS lung mets and AML. Based on the encouraging data seen to date, we are optimistic in Annamycin’s potential to treat a number of indications and remain […]
Double-Digit Objective Response Rate announced in Each Cohort from the Ongoing ENVASARC Ph 2 Pivotal Trial
“We are pleased with the activity of the 600 mg dose of envafolimab that has demonstrated a double-digit objective response rate both as a single agent and in combination with Yervoy, even at this early 12-week time point,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “We are also encouraged with the safety data showing […]
Positive EMA Opinion on Orphan Designation for Ivospemin (SBP-101) + Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
“We are pleased to receive a notification of positive opinion for orphan drug designation from EMA’s Committee Orphan Medicinal Products following its December plenary meeting,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. “The opinion is timely, as we only a few weeks ago announced first patients enrolled in […]
PDUFA date extended by three months to review Lynparza + abiraterone and prednisone /prednisolone sNDA for the treatment of mCRPC
US Food and Drug Administration (FDA) informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time for a full review of the supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant […]
Application in European Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn
“We have elected to withdraw our application seeking approval of ibrutinib, in combination with bendamustine and rituximab in first-line mantle cell lymphoma, in the European Union following discussion with the EMA,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “While we are disappointed that this treatment […]
U.S. FDA announces Accelerated Approval of KRAZATI™ (adagrasib) for Patients with Locally Advanced or Metastatic NSCLC with a KRASG12C Mutation
“The FDA approval of KRAZATI is a positive development for thousands of patients with KRASG12C mutations, including the approximately 14% of patients with NSCLC adenocarcinomas histology that harbor a KRASG12C mutation. Mirati is thrilled to make KRAZATI available in a tablet formulation to patients in the U.S. with advanced NSCLC who have progressed beyond a […]
European Commission Approves Pluvicto® For Treatment Of Progressive PSMA+ve mCRPC
“Today’s approval of Pluvicto® by the European Commission marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease,” said Haseeb Ahmad, President Europe, Novartis. “We are excited by the potential of Pluvicto® to bring groundbreaking clinical benefits to these patients, transforming cancer care for […]
CONFERENCE COVERAGE: 64th American Society of Hematology (ASH) Annual Meeting
