Imfinzi plus bevacizumab met primary endpoint for PFS in liver cancer eligible for embolisation in EMERALD-1 Phase III trial
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These positive results for Imfinzi-based treatment in EMERALD-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we […]
Positive EU CHMP Opinion for KEYTRUDA Plus Gemcitabine and Cisplatin as 1L Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
“Patients diagnosed with locally advanced unresectable or metastatic biliary tract cancer face a challenging disease with poor survival outcomes, underscoring the need for new treatment options that may help extend their lives,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The CHMP’s positive opinion brings […]
US FDA Accepts for Priority Review Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory CLL/SLL
“Currently, there is no standard of care for people living with relapsed or refractory CLL or SLL after treatment with BTKi- and BCL2i-based regimens, leaving a critical unmet need for a treatment option that provides deep and lasting responses,” said Anne Kerber, senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), […]
FDA granted BTD and EMA application validated for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of R/R Follicular Lymphoma
“The FDA granted BTD and validated European application are an important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “Together with Genmab, we are continuing to investigate […]
2nd Independent Safety Review of the ASPIRE Registration Clinical Trial Announced: Recommended Continuation with no Trial Modification
“We are pleased that no safety concerns were identified and the DSMB’s recommendation is to proceed without modification to the ASPIRE Trial. With a focus on enrollment and completing site initiations, we are looking forward to the interim analysis in mid-2024.” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
U.S. FDA Fast Track Designation for BI 764532 for the Potential Treatment of Advanced or Metastatic Large-Cell Neuroendocrine Carcinoma of the Lung
Christian Rohlff, Chief Executive Officer of OBT, commented: “We are delighted about the clinical development to help address unmet needs for people living with small cell lung cancer and other neuroendocrine carcinomas. This is an important milestone for our teams and exciting news for the community”.
FDA Grants Orphan Drug Designation for LP-284 in High-Grade B-cell Lymphomas (HGBL)
“Receiving Orphan Drug Designation is an important milestone for our latest drug candidate, LP-284, and further validates our data-driven approach to oncology drug discovery and development,” stated Panna Sharma, President & CEO of Lantern Pharma. “At SOHO 2023, we reported positive preclinical data demonstrating LP-284’s potent anti-tumor activity as a monotherapy as well as in […]
FDA Accepts and Grants Priority Review for Pz-cel BLA
“The FDA’s acceptance of our BLA for priority review underscores the high unmet need in RDEB and the potential for pz-cel to provide meaningful benefit to these patients,” said Vish Seshadri, Chief Executive Officer of Abeona. “We thank the FDA for their commitment and look forward to working with them through the BLA review, with […]
sBLA submitted to US FDA for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL)
“We are looking forward to continuing working with the FDA through the regulatory approval process,” commented Dr. Christian Itin, Chief Executive Officer of Autolus. “I would like to thank the treating physicians, patients, caregivers, and the dedicated team at Autolus for their support, trust and commitment for the program to reach this important milestone.”
U.S. FDA Fast Track Designation for Zotatifin in Combination with Fulvestrant and Abemaciclib for Treatment of ER+/HER2- Advanced Metastatic Breast Cancer
“We’re grateful to receive this Fast Track designation from FDA, which is a meaningful milestone for the development of zotatifin and reflects the demonstrated potential for zotatifin in combination with fulvestrant and abemaciclib to address unmet needs in ER+/HER2- breast cancer,” said Steve Worland, Ph.D., chief executive officer of eFFECTOR. “We value the opportunities provided […]
FDA Grants Priority Review to sBLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer
“The FDA’s acceptance of this application for priority review, as well as under the RTOR program, underscores the urgency to bring this treatment option that has demonstrated an OS benefit over chemotherapy to more patients with locally advanced or metastatic urothelial carcinoma,” said Dr. Eliav Barr, senior vice president and head of global clinical development, […]
FDA Orphan Drug Designation for LYL845 for the Treatment of Melanoma
“There remains a high unmet medical need for patients with advanced melanoma and we believe LYL845 has the potential for differentiated potency and durability needed to deliver better outcomes for patients with melanoma as well as other solid tumors where TIL therapy has not yet been widely effective,” said Lynn Seely, M.D., Lyell’s President and […]
Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
“Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Subcutaneous administration offers a faster and more convenient alternative to IV infusion. The CHMP’s recommendation brings us a step closer to […]
FDA Plans ODAC Review, Delays PDUFA Date for Idecabtagene Vicleucel
sBLA submitted to to U.S. FDA Seeking Approval of RYBREVANT + Chemo for the Treatment of Patients with EGFRm NSCLC Who Progressed on or after Osimertinib
“New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the […]
Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
Komal Jhaveri, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center (MSK), US, said: “Patients with advanced HR-positive breast cancer typically experience tumour progression or resistance with widely used first-line endocrine therapies and there is an urgent need to extend the effectiveness of these approaches. The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a […]
FDA Approves Augtyro™ (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive NSCLC
“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” said Jessica J. Lin, MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School.4,5,6,7 “Based on […]
U.S. FDA Approves FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer
“There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes. FRUZAQLA is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” said Teresa Bitetti, president of the Global […]
Imfinzi plus chemotherapy approved in China as first immunotherapy regimen for patients with locally advanced or metastatic biliary tract cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this approval for Imfinzi plus chemotherapy, physicians will now be able to offer this global standard-of-care treatment to patients in China, where nearly one in five patients with biliary tract cancer is diagnosed. This important milestone underscores our commitment to bring innovative medicines that […]
European Commission Approves BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma
“With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union. BRUKINSA is now the first BTK inhibitor approved in this indication and has the broadest label of any medicine in its class globally,” said Mehrdad Mobasher, M.D., M.P.H., Chief […]
FDA Approves KEYTRUDA + Chemotherapy as 1L Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or GEJ Adenocarcinoma
“The majority of patients with gastric cancer are diagnosed at an advanced stage, at which point they face a poor prognosis with a five-year survival rate of 6%,” said Dr. Zev A. Wainberg, professor of medicine at University of California, Los Angeles School of Medicine and co-director of the UCLA GI Oncology Program. “This approval […]
Exact Sciences
Exact Sciences was founded in 1995 with the visionary, and perhaps ahead of its time goal of developing non-invasive colorectal cancer (CRC) testing. The company’s early and innovative stool-DNA tests like PreGen-Plus faced financial struggles and regulatory headwinds. The turning point was the 2009 collaboration with the Mayo Clinic for licensing the stool DNA test […]
Aquinnah’s potential Alzheimer’s drug capable of reducing ~70% brain tau pathology
Aquinnah Pharmaceuticals recently announced the preclinical findings on its novel therapeutic designed to slow or stop the progression of Alzheimer’s Disease (AD) and related disorders. Their drug discovery relies on identifying compounds capable of eliminating persistent stress granules. Stress granules are aggregates of proteins and RNA molecules formed as a cell survival process in response to […]
CONFERENCE COVERAGE: 2023 SITC Annual Meeting
Karyopharm Announces Clinical Trial Collaboration with BMS to Evaluate CELMoD Agent CC- 92480 Mezigdomide + Selinexor in Patients with R/R Multiple Myeloma
“This is an important collaboration with Bristol Myers Squibb to explore this novel and entirely oral combination in patients who have progressed following T-cell engaging therapy. This trial will also evaluate mezigdomide-selinexor plus dexamethasone in patients with relapsed/refractory multiple myeloma who need an effective alternative to T-cell therapies,” said Richard Paulson, MBA, President and Chief […]
Prelude Therapeutics and AbCellera Enter Partnership to Develop First-in-Class Precision ADCs in Oncology
“We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program. Based on this assessment, we are prioritizing our resources on our first-in-class SMARCA2 degrader molecules, IV and oral, and our potential best-in-class CDK9 inhibitor program,” stated Kris Vaddi, Ph.D., Chief Executive […]
Merck Strengthens Oncology Pipeline Through Strategic Partnership with Hengrui for Next-Gen Selective PARP1 Inhibitor and Antibody-Drug Conjugate
“This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage response inhibition and antibody-drug conjugates,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business of […]
AstraZeneca announces collaboration and investment agreement with Cellectis to accelerate cell therapy and genomic medicine ambitions
Marc Dunoyer, Chief Strategy Officer, AstraZeneca, and Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: “The differentiated capabilities Cellectis has in gene editing and manufacturing complement our in-house expertise and investments made in the past year. AstraZeneca continues to advance our ambition in cell therapy for oncology and autoimmune diseases as well as in genomic […]
Partial Clinical Hold For NX-2127 Phase 1 Trial Announced
“The initial NX-2127 manufacturing process produced a Phase 1 drug product that has yielded important proof-of-concept results with meaningful clinical responses in patients with advanced B-cell malignancies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “While the partial hold is in effect, we will supply the current drug product for […]
Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer Announced
“No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients. Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed.”
