BLA Review for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) by FDA remains pending
“Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in […]
Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated CRC
“KRASG12C-mutations occur in 3-4% of colorectal cancers and are associated with poor outcomes. Few effective treatment options exist for these patients,” said Alan Sandler, M.D., Chief Medical Officer. “We are encouraged by this data, particularly adagrasib in combination with cetuximab. With the BTD status, we look forward to working together with the FDA to potentially […]
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.”
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 […]
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 […]
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 […]
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
CONFERENCE COVERAGE: 2022 San Antonio Breast Cancer Symposium (SABCS)
Kite And Arcellx Announce Strategic Collaboration To Co-Develop And Co-Commercialize Late-Stage Clinical CART-DdBCMA In Multiple Myeloma
“The collaboration with Arcellx enables Kite to expand into a new area of high unmet need and bring a potentially best-in-class cell therapy to help many patients,” said Christi Shaw, Chief Executive Officer of Kite. “Cell therapy has proven it can change the way cancer is treated by creating a potentially curative therapy for an […]
Replimune Enters into Clinical Collaboration Agreement with Roche for the Development of RP3 In CRC and HCC
“This collaboration announcement is in keeping with our philosophy of partnering with industry leaders in oncology and in indications where our immunotherapies have the potential to become a key cornerstone of treatment,” said Pamela Esposito, Ph.D., Chief Business Officer of Replimune. “With similar collaborations already in place for our lead candidate RP1 with Regeneron and […]
FDA Lifts Clinical Hold on the Investigational New Drug Application for BEAM-201
“The FDA’s clearance of our IND for BEAM-201 is an exciting moment for Beam and for the field of gene editing, as it represents the first IND clearance for a multiplex-base edited investigational drug,” said John Evans, chief executive officer of Beam. “We believe the future of cell therapy involves high levels of cell engineering, […]
Pluvicto™ shows statistically significant and clinically meaningful rPFS benefit in patients with PSMA–positive mCRPC
“With the announcement of these positive topline Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “We look forward […]
PERLA Ph 2 trial of Jemperli (dostarlimab) plus chemotherapy shows positive results in 1L mNSCLC
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “The head-to-head data from the PERLA trial showed that dostarlimab combined with chemotherapy provided robust anti-tumour activity in patients with previously untreated metastatic non-squamous non-small cell lung cancer. The positive results from this trial inform our future development plans and highlight the potential […]
U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with R/R KMT2A- Rearranged (MLLr) Acute Leukemia
“The Breakthrough Therapy Designation underscores revumenib’s potential as a first- and best-in-class therapy to meaningfully change the treatment paradigm for patients with R/R KMT2Ar acute leukemia, whether it presents clinically as acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL), in adults or children,” said Michael A. Metzger, Chief Executive Officer. “Revumenib has the potential, […]
BLA submitted to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through our discovery and development of talquetamab, a novel GPRC5DxCD3 bispecific antibody, we remain relentlessly […]
Immutep Enters into 2nd Clinical Trial Collaboration Agreement with Merck & Pfizer for New trial of Eftilagimod Alpha and Avelumab to Treat Urothelial Cancer
“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options,” said Immutep CEO, Marc Voigt. “INSIGHT-005 builds on the encouraging clinical efficacy and safety previously […]
AstraZeneca to acquire Neogene Therapeutics
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This acquisition represents a unique opportunity to bring innovative science and leading experts in T-cell receptor biology and cell therapy manufacturing together with our internal oncology cell therapy team, unlocking new ways to target cancer. Neogene’s leading TCR discovery capabilities and extensive manufacturing experience complement the […]
Ph 1 Trial of E6201 + Dabrafenib initiated in Patients with CNS Metastases from BRAF V600 Mutated Metastatic Melanoma
“E6201 is a potent MEK1 inhibitor. Exceptional responses were seen with E6201 monotherapy in patients with melanoma brain metastases in our prior Phase 1 studies. By utilizing a targeted drug against BRAF- or MEK-mutated melanoma CNS metastases with excellent brain penetration and retention, we hope to provide a more effective therapeutic in combination with dabrafenib […]
SAPPHIRE Ph 3 study of sitravatinib + nivolumab in patients with chemo- and IO-resistant 2L/3L NSQ-NSCLC will continue to the study’s final analysis
“We remain committed to developing our portfolio of oncology candidates and advancing our lung cancer strategy to positively impact the lives of patients with cancer. We look forward to providing an update based on the full analysis of the SAPPHIRE study in mid-2023,” said Charles Baum, M.D., Ph.D., president, founder and head of research and […]
Jemperli (Dostarlimab-Gxly) RUBY Ph 3 Trial Met Its Primary Endpoint In A Planned Interim Analysis In Patients With Primary Advanced Or Recurrent Endometrial Cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “Patients with primary advanced or recurrent endometrial cancer have limited treatment options. Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy. Based on these positive headline results from the RUBY […]
New Data from the OLYMPUS Trial Shows mDOR of 28.9 Months for JELMYTO for Adults with Low-Grade Upper Tract Urothelial Cancer
“The clinical benefit of JELMYTO was demonstrated in the Phase 3 OLYMPUS study and data presented today highlighted the long-term durability of that benefit,” said Dr. Phillip Pierorazio, M.D., Chief, Section of Urology at Penn Presbyterian Medical Center, Philadelphia, PA. “JELMYTO provides an effective and durable kidney-sparing treatment option and should be considered as primary […]
FDA Fast Track Designation to pelareorep + atezolizumab + chemotherapy for the Treatment of Advanced/Metastatic Pancreatic Cancer
“Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication,” stated Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech […]
