TAGRISSO + chemo demonstrated strong improvement in PFS for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial
Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: “As the global standard of care for EGFR-mutated non-small cell lung cancer, osimertinib monotherapy has transformed the treatment landscape allowing many patients the opportunity to achieve improved survival. FLAURA2 provides compelling evidence that the addition of […]
IMFINZI + LYNPARZA and IMFINZI alone both significantly improved PFS in advanced endometrial cancer when added to chemotherapy
Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at the University of Texas MD Anderson Cancer Center, and principal investigator of the DUO-E trial, said: “These exciting data demonstrate durvalumab immunotherapy can significantly delay disease progression for patients with endometrial cancer and the addition of the PARP inhibitor olaparib can improve the benefit […]
U.S. FDA Issues Complete Response Letter for [Vic-]Trastuzumab Duocarmazine
While Byondis is disappointed with this outcome, the company remains optimistic about SYD985’s potential. “We continue to believe that SYD985 can present a meaningful treatment option for patients living with HER2-positive metastatic breast cancer,” said Byondis CEO Marco Timmers, Ph.D. “We appreciate the FDA’s guidance and support and will carefully evaluate the complete response letter […]
Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer
Immutep CEO, Marc Voigt, commented: “In light of our compelling clinical data that efti has generated in combination with anti-PD-1 therapy, this meeting with the FDA is a critical step in our late-stage development process for 1st line non-small cell lung cancer. We are thankful for the positive feedback as we continue moving forward with […]
Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers
“We believe the that Orphan Drug Designation represents an important regulatory milestone for ATG-022, recognizing the significant and urgent unmet need for new treatments to help patients who are fighting difficult to treat and devastating diseases such as pancreatic and gastric cancers,” said Dr. Amily Zhang, Antengene’s Chief Medical Officer. “We are enthusiastic about the […]
U.S. IND for the Phase I Trial of ATG-031 announced
“Targeting the so-called ‘don’t eat me’ signal is a promising therapeutic strategy for cancer treatment. In comparison to existing ‘don’t eat me’ blockers such as anti-CD47 monoclonal antibodies, ATG-031 demonstrated a wider therapeutic window and the ability to overcome the on-target-off-tumor toxicities observed with CD47 inhibitors,” said Dr. Bing Hou, Antengene’s Executive Director of Drug […]
Type II variation application to EMA submitted for a new indication for CARVYKTI in adult patients with relapsed and lenalidomide-refractory multiple myeloma
“The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy […]
FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
“Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S.,” said Mel Sorensen, M.D., Galera’s President and CEO. “Following our announcement of encouraging survival results from our pilot proof-of-concept trial in patients […]
Positive CHMP Opinion to Opdivo + Chemo as Neoadjuvant Treatment of Resectable NSCLC at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression
“The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to […]
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023
“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “There are significant needs for patients with this disease in the U.S., and we […]
FDA Accepts BLA of Lifileucel for the Treatment of Advanced Melanoma
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor. The FDA’s commitment to a six-month Priority Review validates the unmet need and urgency for new treatment options […]
EPKINLY (epcoritamab-bysp) Approved by FDA to Treat Adult Patients with R/R DLBCL
“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient […]
VANFLYTA First FLT3 Inhibitor Approved in Japan for Patients with Newly Diagnosed FLT3-ITD Positive AML
“Patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia now will have the opportunity to receive targeted therapy with VANFLYTA,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “VANFLYTA is the only medicine developed and approved specifically for treatment of newly diagnosed FLT3-ITD positive AML in Japan and has […]
Gilead Strengthens Early Pipeline In Oncology And Inflammation Through The Acquisition Of XinThera
“Gilead and XinThera share similar missions to discover new therapies to treat cancer and inflammatory diseases, which drive our determination to unlock the body’s ability to better respond to these diseases,” said Chris LeMasters, who served as XinThera CEO. “We are eager to join Gilead and together explore the potential of our precision medicines as […]
Bayer and Bicycle Therapeutics Enter Strategic Collaboration for Development of Novel Targeted Radionuclide Therapies in Oncology
“At Bayer, we enter strategic collaborations to expand our access to innovation,” said Christian Rommel, Ph.D., Global Head of Research and Development and Member of the Executive Committee, Pharmaceuticals Division, Bayer. “With Bicycle’s proprietary peptide-based technology, we continue to strengthen our oncology development pipeline by adding next-generation targeted radiotherapeutics to address high unmet medical needs […]
FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics
“The agreement with Fortis Therapeutics bolsters FibroGen’s clinical pipeline in a capital-efficient manner, providing a product candidate with the potential to address a significant unmet medical need in oncology,” said Enrique Conterno, Chief Executive Officer, FibroGen. “FOR46 is a natural fit with our R&D capabilities and expertise. The flexibility of the agreement gives us the […]
Eisai entered into a joint development agreement with BlissBio for ADC BB-1701
“BB-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “Our collaboration with BlissBio will accelerate the development of BB-1701 […]
CytoMed Therapeutics Announces Research Collaboration with Cancer Treatment Center to Advance Allogeneic Off-the-Shelf Gamma Delta T Cells in Oncology
“Interest in the potential of our allogeneic immunotherapy platform to provide additional treatment options has been strong,” said Dr Tan Wee Kiat, Chief Operating Officer at CytoMed, “and international collaborations are a key part of our strategy to maximize our impact.”
Zion Pharma Announces Global Agreement with Roche to develop and commercialize a blood brain barrier penetrant oral HER2 tyrosine kinase inhibitor
“Our agreement with Roche is the culmination of a tremendous team effort to deliver a potentially best-in-class therapy for patients with HER2-positive breast cancer, particularly in the field of brain metastasis by virtue of the high blood-brain barrier permeability of this asset”, stated Zack Cheng, M.D., Ph.D., Chairman, CEO and Co-Founder of Zion Pharma Limited. […]
Alligator Bioscience and Orion Corporation announce exercise of development option under their 2021 Immuno-oncology Research Collaboration and License Agreement
“The research collaboration conducted with Alligator to date has allowed us to identify several lead molecules which have potential to be selected for clinical development, making us keen to intensify and accelerate the research and nonclinical development of these compounds to have a final development candidate as soon as possible,” said Outi Vaarala, Senior Vice […]
First Patient Dosed in Ph I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in NSCLC
“We are pleased to initiate this first-in-human trial of TG6050 administered intravenously in patients with recurrent/metastatic advanced non-small cell lung cancer in great need for effective new therapeutic options,” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. “Intravenous administration of TG6050 aims at significantly enhance the therapeutic potential of this promising oncolytic […]
First Patient Treated in Ph 3 HARMONi Clinical Trial Evaluating Ivonescimab (SMT112)
“Advanced or metastatic non-small cell lung cancer is such a devastating diagnosis for patients,” said Ian Anderson, M.D., Medical Oncologist at Providence Medical Foundation, who treated the first patient in HARMONi. “While we are making great strides as a medical community to improve the quality and duration of patients’ lives, there remains significant room for […]
New Results from Ph 2 Trial Confirm Benefit of Trilaciclib in Reducing Adverse Events Related to an ADC
“These preliminary results continue to show the consistent benefit of trilaciclib when administered prior to sacituzumab, relative to the previously published single agent safety profile of this ADC, including greater than 50 percent reductions in the incidence of events including neutropenia, anemia, and diarrhea,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “It […]
OS results from Elahere’s Ph 3 MIRASOL trial announced
“We are honored that MIRASOL has been selected as a late-breaker presentation at ASCO, and pleased that we will be able to share the results from the trial so quickly after they became available,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “Having demonstrated a statistically significant and clinically meaningful […]
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma
“We are glad to see the NMPA grants another Breakthrough Therapy Designation based on the preliminary results of IBI351 monotherapy in advanced colorectal carcinoma.” said Dr. Hui Zhou, Senior Vice President of Innovent. “The prognosis of advanced colorectal carcinoma patients with KRASG12C mutation is worse than KRAS wild type patients with limited therapeutic options. Currently, […]
Type A Meeting scheduled with the U.S. FDA to Review Proposed Study Design for a Second Ph 3 Study Evaluating HyBryte™ in the Treatment of CTCL
“Responding to FDA feedback, Soligenix has submitted a confirmatory Phase 3 draft study protocol retaining the key aspects of the first Phase 3 trial,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We look forward to discussing the protocol in detail with FDA. We intend to provide a further update once […]
The China NMPA Approves TYVYT® + Bevacizumab + Chemotherapy in Patients with EGFR-mutated nsqNSCLC who Progressed after EGFR-TKI Therapy
The principal investigator of the ORIENT-31 Study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, “Different from the western population, about half of the Chinese patients with NSCLC have EGFR mutations. EGFR-TKI targeted therapy is the first line treatment choice in NSCLC patients with EGFR sensitive mutation. However, almost all patients […]
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
“The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options. With today’s approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe. This further affirms our unparalleled scientific leadership in harnessing the IDH mutation and commitment to finding new […]
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
“The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options. With today’s approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe. This further affirms our unparalleled scientific leadership in harnessing the IDH mutation and commitment to finding new […]
Zai Lab Announces Strategic Partnership and Global License Agreement with MediLink Therapeutics for a Next Gen ADC Program in Oncology
“We are excited to collaborate with MediLink on this program. We will leverage our capabilities to advance the global development of YL212,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “This collaboration demonstrates our continued focus on developing cancer therapies including ADC drugs, further enriching our global […]
