U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” said Levi Garraway, M.D., Ph.D., chief medical […]
FDA Approves REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
“REZLIDHIA is a novel, non-intensive monotherapy treatment in the relapsed/refractory AML setting demonstrating a CR+CRh rate of 35% in patients with over 90% of those responders in complete remission. The 25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options,” said […]
Lyvgen Announces Ph 2 Clinical Collaboration with Bristol Myers Squibb to Evaluate LVGN7409 in Combination with Nivolumab in NSCLC Patients
“Lyvgen clinical collaboration with Bristol Myers Squibb underscores our commitment to exploring combination regimens from our portfolio with complementary mechanisms of action that may transform cancer care”, said Jieyi Wang, Ph.D., Founder and CEO of Lyvgen. “We are excited to enter this clinical collaboration with Bristol Myers Squibb and look forward to initiating enrollment in […]
C4XD signs exclusive global licence worth up to $402 million with AstraZeneca for the development and commercialisation of NRF2 Activator programme
Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “At AstraZeneca, we are committed to transforming care in respiratory and immune-mediated disease and move beyond symptom control. Our alliance with C4XD adds an important new asset to our portfolio to push the boundaries of science by targeting underlying disease drivers to potentially modify the […]
First Patient Dosed in Ph 2 ‘IPAX-Linz’ Study of TLX101 for Glioblastoma Therapy
Prof. Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in the IPAX-Linz study said, “Based on promising safety and early efficacy data for TLX101 in the IPAX-1 study, I am pleased to continue to explore this therapeutic modality in a larger patient cohort, where there are currently few effective treatment options. Preliminary results are only […]
Positive Update On Joint TIGIT Program From Interim Analysis Of ARC-7 Study In NSCLC Announced
“The efficacy measures observed, including PFS, reinforce confidence in the TIGIT pathway. The interim results show that combining two checkpoint inhibitors – an anti-TIGIT and an anti-PD-1 – delivered added benefit beyond anti-PD-1 monotherapy in this setting,” said Melissa L. Johnson, M.D., Director Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and Lead […]
ARV-471 Achieves a CBR of 38% in Evaluable Patients and Continues to Show a Favorable Tolerability Profile in its Ph 2 Expansion Trial (VERITAC)
“I’m gratified to see the continued differentiated profile of ARV-471 and its potential to become an important new standard of care for patients with ER+/HER2- breast cancer,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “The positive VERITAC results, in a heavily pre-treated population in which 100% of the patients received at […]
Ph 3 KEYNOTE-859 Trial Met Primary Endpoint of Overall Survival in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
“Despite improvements in cancer care, advanced gastric cancer continues to have one of the lowest five-year survival rates, and new interventions are urgently needed. The results from KEYNOTE-859 show the potential of KEYTRUDA plus chemotherapy to improve survival beyond chemotherapy alone for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, […]
U.S. FDA Accepts for Priority Review the BLA for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R Large B-Cell Lymphoma
“We are committed to the research and development of innovative therapies to provide important treatment options for people living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “This milestone signals an early step […]
FDA issued CRL indicating the poziotinib application cannot be approved in its present form; company to deprioritise the program
“While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “We continue to […]
ENHERTU® Approved in Japan for Patients with Previously Treated HER2 Positive Metastatic Breast Cancer
“We are proud of the quality and speed in which we were able to deliver a confirmatory phase 3 trial that demonstrated the superiority of ENHERTU in prolonging progression-free survival compared to T-DM1 in patients with previously treated HER2 positive metastatic breast cancer,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, […]
Jnana Therapeutics Announces Second Collaboration with Roche to Address Challenging-to-Drug Targets in Cancer, Immune-Mediated and Neurological Diseases
“We are excited to partner with Roche, one of the largest healthcare companies and a strong collaborator, for a second time,” said Joanne Kotz, Ph.D., co-founder and CEO of Jnana Therapeutics. “Roche has been a valuable strategic partner and we are proud that our success to date has led to the opportunity to broaden our […]
Positive Top-Line Results From Ph 3 Trial of DCVax®-L for Glioblastoma announced
Ms. Powers, CEO of NW Bio, commented: “We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the “long tail” of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical […]
Ph 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL
“Ph+ ALL is a fast-progressing disease with no targeted treatments currently approved in the frontline for patients in the U.S. There is an urgent need for an effective treatment that can suppress the development of difficult-to-treat mutations, which are associated with poor long-term outcomes,” said Awny Farajallah, MD, Head of Global Medical Affairs Oncology at […]
BLA Submission for Lifileucel in Advanced Melanoma delayed
Frederick Vogt, Ph.D., J.D., Iovance’s Interim President and Chief Executive Officer stated, “We continue to make substantial progress with our ongoing BLA submission and remain close to the finish line. The FDA has provided recent valuable feedback to the IND application and remains supportive during the rolling BLA submission process. Iovance is fully committed to […]
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer
Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, Inc, said: “Enhertu is the first HER2-directed medicine to demonstrate a significant improvement in overall survival compared to chemotherapy in patients with gastric cancer following initial treatment with a HER2-directed medicine in the advanced or metastatic setting. The CHMP opinion recognises the high unmet need in this […]
FDA grants Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
“The approval of ELAHERE is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes,” said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. “ELAHERE’s impressive anti-tumor activity, […]
Exelixis and Catalent Enter into New License Agreement for Three Antibody-Drug Conjugate Programs with the Potential to Accelerate Exelixis’ Biologics Pipeline
“Exelixis is committed to building a robust biologics pipeline, and this agreement expands our portfolio to include three highly promising targets with broad potential in multiple solid tumor indications, including bladder, breast, lung, ovarian, pancreatic, and other cancers,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. “We believe that […]
IO Biotech and Merck to Evaluate Neoadjuvant and Adjuvant IO102-IO103 With KEYTRUDA® (pembrolizumab) in a Ph 2 Trial in Patients with Resectable Tumors
“We are pleased to extend our collaboration with Merck into this new exploration of IO102-IO103 in combination with pembrolizumab in earlier, neoadjuvant and adjuvant settings,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “IO102-IO103 has shown promising early clinical activity with a positive safety profile in melanoma thus far and, as highlighted in […]
Ph 3 trial of SYK inhibitor, entospletinib, for the treatment of newly diagnosed patients with NPM1-mutated AML to be discontinued
“Focusing on lanraplenib and KB-0742 will allow us to direct our resources to the highest value programs and deliver on our mission of bringing cancer drugs to the patients with the greatest need,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “This is the right decision at the right time, and […]
First Patient Dosed in Ph 1/2 Clinical Trial Evaluating MRT-2359, a GSPT1-directed Molecular Glue Degrader, for Treatment of MYC-driven Tumors
“MYC transcription factors are well-defined drivers of human cancers, and disrupting protein translation has emerged as a promising path to address this highly prevalent disease pathway. Dosing the first patient is a significant milestone in developing MRT-2359 as a therapeutic option for MYC-driven cancers,” said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa. […]
First Patient Successfully Dosed in Ph 1 Study of Pindnarulex in Combination with Talazoparib for the Treatment of Prostate Cancer
“Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. Therefore, we think Pidnarulex demonstrates great potential as an alternative treatment for prostate cancer patients who have acquired resistance to PARPi or other chemotherapies,” said Dr. Jin-Ding Huang, Chief Executive Officer of Senhwa Biosciences.
New Positive Data from Ongoing Ph 1 Trial of CUE-101 in Combination with KEYTRUDA(R) for Recurrent/Metastatic HPV+ Head and Neck Cancer presented
“We are very encouraged with the overall response rate observed in the trial so far with CUE-101, and its potential to improve standard of care for HPV+ head and neck cancer patients,” said Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the clinical […]
Onivyde® Regimen Demonstrated Statistically Significant Improvement In Overall Survival In Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
“The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated,” said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. “The prognosis for people diagnosed with pancreatic […]
Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
“The FDA’s Breakthrough Designation recognizes the potential of elranatamab as an innovative medicine for people with multiple myeloma whose disease has relapsed or is refractory to existing treatments, which at present leaves very few avenues for staving off this currently incurable cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer […]
Imfinzi and Imjudo with chemotherapy approved in the US for patients with mNSCLC based on POSEIDON Phase III trial results
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval underscores the importance of delivering novel treatment combinations that extend survival in metastatic non-small cell lung cancer, a complex setting where many patients still face a dismal prognosis. This marks the second indication for Imjudo added to Imfinzi in just a few weeks […]
New recommendations for influenza vaccine composition
“The World Health Organization has announced the recommended viral composition of influenza vaccines for the 2023 southern hemisphere influenza season. The recommendations issued today will be used by national vaccine regulatory agencies and pharmaceutical companies to develop, produce, and license influenza vaccines for the following influenza season. The periodic update of viruses contained in influenza […]
Obsidian Therapeutics Announces Extension of Multi-Year Collaboration Agreement with BMS
“We are delighted to extend our productive strategic partnership with Bristol Myers Squibb, an industry leader in the field, to advance next-generation cell therapies to patients with solid tumors and other malignancies,” said Paul K. Wotton, Ph.D., Chief Executive Officer of Obsidian Therapeutics. “This announcement comes at an exciting time for Obsidian as our own […]
Enrollment of Davoceticept Clinical Studies (NEON-1 and NEON-2) Terminated
“Patient safety remains our highest priority,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “We have determined it is in the best interest of all patients to terminate enrollment in the davoceticept studies and we will continue to work with the U.S. Food and Drug Administration, Merck, the study Safety […]
First Patient Dosed in Landmark MYCHELANGELO™ I Trial of OTX-2002 in HCC and Other Solid Tumor Types Associated with the MYC Oncogene
“Today’s announcement marks a new era of therapeutic development utilizing precision genomic control intended to treat and cure serious diseases. As the first-ever Omega Epigenomic Controller™ (OEC) to be dosed in a patient, this milestone for OTX-2002 and the MYCHELANGELO clinical program represents a significant step forward on our mission to deliver a new approach […]
