Fast Track Designation for IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients with BRCA1/2 Mutations
“We are extremely pleased to receive the U.S. FDA Fast Track designation for IDE161 based on the FDA’s review of preclinical and emerging clinical efficacy and tolerability data. We recently reported preliminary clinical proof-of-concept with expansion into priority HRD+ solid tumor indications in our Phase 1 clinical trial. The Fast Track designation has been provided […]
Fast Track Designation for IDE161 for the Treatment of Pretreated, Advanced or Metastatic HR+, HER2-, BRCA1/2 mutant Breast Cancer
“The U.S. FDA Fast Track designations for our potential first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant breast and ovarian cancers reflect the potential for IDE161 to address the significant unmet medical need in these indications,” said Dr. Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences. “We are excited that IDE161 has been granted Fast Track […]
FDA grants Fast Track Designation to MYTX-011 for Patients with NSCLC with cMET Overexpression
“Receiving Fast Track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments,” said Brian Fiske, PhD, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. “We are proud of this significant milestone as it highlights the potential of MYTX-011, which is […]
European Commission Approves Enrylaze for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
“Asparaginase is a core component of multi-agent chemotherapeutic regimens for the treatment of ALL, however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase, resulting in a delay or disruption in treatment,” said Professor Carmelo Rizzari, Department of Pediatrics, University of Milano-Bicocca, Head of the Pediatric Hematology Oncology Unit, Foundation IRCCS San Gerardo […]
European Commission Approves TEPKINLY (epcoritamab) for Adults with R/R DLBCL
“With TEPKINLY, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Today’s approval underscores our commitment to bringing our bispecific antibody […]
MHLW approves Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer
“We are pleased to have obtained approval in Japan for Phesgo, a fixed-dose combination for subcutaneous use containing the same anti-HER2 agents of Perjeta® and Herceptin®, the standard therapy for HER2-positive breast cancer. Reducing administration time is expected to improve convenience for patients and reduce the burden on healthcare system and professionals. We are preparing […]
BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®
“We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine. These are significant milestones for people with advanced or metastatic ESCC, as tislelizumab has been shown to deliver clinically meaningful survival benefit as monotherapy and in combination with chemotherapy […]
1ST Biotherapeutics Announces Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate FB849 in Combination With KEYTRUDA
“We are very pleased to mark the next stage of FB849’s development with this exciting collaboration. We are hopeful that combining FB849 with KEYTRUDA may induce an effective anti-tumor response and show an additive benefit for patients with advanced solid tumors,” said Jamie Jae Eun Kim, Ph.D., Founder and Chief Executive Officer of 1ST Biotherapeutics. […]
Collaborative Trial to Study PP2A Inhibitor, LB-100, Plus Dostarlimab, in Clear-Cell Ovarian Cancer announced
John S. Kovach, M.D., LIXTE’s founder and Chief Executive Officer, said, “Preclinical data supports the idea that LB-100 enhances the efficacy of PD-1 therapy.1 Clinical data also supports this idea, in that patients with ovarian clear cell carcinoma with dysfunctional PP2A due to somatic mutations in PPP2R1A have shown dramatically longer survival after treatment with […]
Boundless Bio Announces Clinical Trial Collaboration & Supply Agreement with Taiho Oncology to Evaluate LYTGOBI + BBI-355 in Patients with FGFR Amplified Solid Tumors
This clinical trial collaboration and supply agreement with Taiho marks an important step in the continued execution of our clinical strategy and the next step in realizing the transformative potential of BBI-355, which we believe is the first ecDNA-directed therapy in development for patients with cancer that harbor oncogene amplifications on ecDNA,” said Zachary Hornby, […]
Boundless Bio Announces Clinical Trial Collaboration & Supply Agreement with Lilly to Evaluate VERZENIO + BBI-355 in Patients with CDK4/6 Amplified Solid Tumors
“We are pleased to enter this supply agreement with Lilly to evaluate the combination of BBI-355 and abemaciclib in patients with ecDNA-driven solid tumors harboring CDK4 or CDK6 amplifications in our ongoing POTENTIATE trial,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “To date, CDK4/6 inhibitors have only been approved in HR+/HER2- […]
Roche partners with PeptiDream on peptide-radioisotope drug conjugates
“We are extremely excited to announce this new collaboration with Genentech for the discovery and development of peptide-RI drug conjugates. PeptiDream is a global leader in the discovery and development of peptide-RI conjugates, and through our PDRadiopharma, is one of the leading radiopharmaceutical companies in Japan. Combining this expertise with Genentech’s powerful clinical development and […]
Debiopharm and SunRock Biopharma Partner to Advance Antibody Drug Conjugates for Hard-to-treat Cancers
“Our partnership with SunRock could result in the creation of highly innovative antibody-drug conjugates with the potential to tackle cancer in a new way and ultimately improve the lives of cancer patients,” commented Bertrand Ducrey, CEO of Debiopharm. “In a time when few new modalities show promise in effectively beating cancer, the potential of this […]
Phase 2 Study of Masofaniten (EPI-7386) + Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer initiated
“Initiation of the randomized Phase 2 portion of this study investigating the combination of masofaniten and enzalutamide (the “Combination”) is a significant milestone for ESSA and we look forward to reporting updated results from the Phase 1 dose equilibration portion of the study next month at ESMO 2023,” stated David Parkinson, M.D., President and CEO […]
First Patient Dosed in Phase I/IIa Clinical Study on HPV.DCVax in HPV-positive Oropharyngeal Cancer
Valérie Bouchara, Head of Clinical Operations at LinKinVax, commented: “This first administration is a major milestone in the development of our therapeutic cancer vaccine CD40HVac. Our teams are committed to uniting their efforts to bring significant innovations to patients with limited therapeutic options, particularly those with recurrent and/or metastatic HPV-positive cancers.”
First Patients with SCLC Dosed in HPN328 Combination Cohort
“Dosing the first patients in these combination cohorts for HPN328 with atezolizumab in patients with SCLC marks a significant milestone for this clinical program,” said Luke Walker, M.D., Chief Medical Officer for Harpoon Therapeutics. “Building on the strength of our Phase 1 data, we remain committed to realizing the full potential of HPN328 as an […]
First Patient dosed in Phase 1/2 Trial of IMPT-314 for the Treatment of Aggressive B-cell Lymphoma
“We are pleased to have treated the first patient with IMPT-314 and build on the clinical evidence from the ongoing investigator-led study of this dual-targeted CD19/CD20 CAR T-cell therapy. We believe IMPT-314 may improve tolerability and durability of responses in patients with B-cell lymphomas and therefore has best-in-class potential,” said Jonathan Benjamin, M.D., Ph.D., chief […]
First Patient in Phase 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ
“The ADVANCED-2 trial in NMIBC is an exciting opportunity to build on the favorable anti-tumor and safety data of TARA-002 presented earlier this year,” said Tom Jayram, M.D., Director, Advanced Therapeutics Center, Urology Associates, P.C., TN and study investigator for the ADVANCED-2 trial. “There is significant need for new intravesical approaches for NMIBC, which can […]
FAILED TRIALS: Phase 3 trials, LEAP-006 and LEAP-008, of KEYTRUDA + LENVIMA in patients with certain types of mNSCLC did not meet primary endpoints of OS & PFS
“As a leader in lung cancer research, we continue to try to advance science for our patients by building upon the standard we set several years ago with KEYTRUDA,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “While these results are not what we hoped for, we are proud of the […]
PADCEV and KEYTRUDA Significantly Improve OS and PFS in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial
Roger Dansey, M.D., President, Research and Development, Seagen, “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer. We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon […]
Yescarta Demonstrates High Response Rate And Durable Remission In ALYCANTE Study As Initial Treatment For Transplant Ineligible Patients With R/R LBCL
“Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Prof. Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study. “ALYCANTE is the first study to assess axicabtagene ciloleucel as second-line therapy for transplant ineligible R/R LBCL and the results showed high response […]
Datopotamab deruxtecan demonstrated statistically significant PFS benefit in patients with HR-positive, HER2-low/neg breast cancer in TROPION-Breast01 Phase III trial
Ken Takeshita, MD, Global Head, Oncology R&D, Daiichi Sankyo, said: “The positive topline results from TROPION-Breast01 demonstrate the potential for datopotamab deruxtecan to become an important treatment option for patients with HR-positive, HER2-low or HER2-negative breast cancer in the second-line metastatic setting. We look forward to realising the full potential of this TROP2-directed antibody drug […]
Perioperative Regimen of Neoadjuvant Opdivo and Chemotherapy Followed by Adjuvant Opdivo Significantly Improves EFS in Patients with Resectable NSCLC
“We’ve seen tremendous scientific advancements in the treatment of non-metastatic non-small cell lung cancer in recent years, and remain committed to researching new solutions that may help even more patients achieve better long-term outcomes,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “Taken together with the data from our […]
Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of OS and PFS in Certain Patients With 1L Locally Advanced or Metastatic Urothelial Cancer
“The results of this pivotal Phase 3 study are highly encouraging and showed a statistically significant survival benefit for the combination of KEYTRUDA with the antibody-drug conjugate enfortumab vedotin in cisplatin-eligible or cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma,” said Dr. Eliav Barr, senior vice president and head of global clinical […]
FDA Accepts for Priority Review sNDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC
“Patients with advanced RCC whose cancer progresses following immune checkpoint and anti-angiogenic therapies face a poorer prognosis, and for those patients, there is a crucial unmet need for new options with an alternative mechanism of action,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The […]
IND Clearance from FDA for Phase 1 Initiation for LP-284 in NHL
“This is now our second novel drug candidate to receive IND clearance from the FDA in the past 100 days, further validating our approach of leveraging AI and machine learning to accelerate the development of our pipeline,” stated Panna Sharma, Lantern’s President and CEO. “LP-284 holds blockbuster potential, and we have been able to expedite […]
FDA Orphan Drug Designation for Alisertib for the Treatment of SCLC
“Obtaining Orphan Drug Designation from the FDA signifies our continued progress and commitment to the development of alisertib for the treatment of small cell lung cancer,” said Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma. “There is an urgent need for new treatments for patients with small cell lung cancer, and we […]
U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma
“The KT-333 Fast Track designation highlights the promise of degrading STAT3, a protein that has historically been undruggable, for the treatment of patients with CTCL and PTCL,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “We look forward to providing an update on the KT-333 Phase 1 clinical trial later this year, including initial […]
FDA Grants US Orphan Drug Designation to MDX-124
Medannex CEO Ian Abercrombie said: ‘This is another significant milestone in the evolution of Medannex and MDX-124. We are delighted to receive such an endorsement from the FDA based on a very strong non-clinical package. This will strengthen our position in the world’s largest healthcare market and we look forward to commencing our clinical programme […]
FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
“The standard of care for patients with locally advanced cervical cancer has not changed in more than two decades, and the majority of patients will experience recurrence or progression of their disease,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “If approved, KEYTRUDA will be the first immunotherapy available for patients […]
