Takeda’s ICLUSIG Receives FDA Approval for Frontline Treatment of Ph+ Acute Lymphoblastic Leukemia
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Takeda recently announced a significant milestone in cancer treatment with the U.S. Food and Drug Administration (FDA) granting accelerated approval for the supplemental New Drug Application (sNDA) of ICLUSIG® (ponatinib). This approval marks a crucial advancement in the treatment landscape for adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). ICLUSIG targets […]
A for Acromegaly – Part I
Acromegaly is a rare, acquired and slowly progressive condition caused by excessive production of growth hormone (GH) by the pituitary gland, due to the presence of a “pituitary adenoma”, a benign tumor. The pituitary gland is a pea-sized endocrine gland located at the base of the skull, in charge of producing several essential hormones and […]
FDA Approves Inotuzumab Ozogamicin for Pediatric Acute Lymphoblastic Leukemia
The Food and Drug Administration (FDA) has granted approval for inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This approval marks a significant advancement in the treatment landscape for this challenging condition. Inotuzumab ozogamicin functions by targeting CD22-positive B-cell precursor […]
Personal Genome Diagnostics
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Personal Genome Diagnostics (PGDx) specializes in developing genomic products for cancer diagnosis. Combining next-generation sequencing, bioinformatics, and oncology expertise, PGDx pioneers advanced diagnostic approaches to identify genomic alterations that guide therapy selection and monitoring. Founded in 2010 by Luis Diaz and Victor Velculescu based on technology developed at the Johns Hopkins University, the company has […]
Care For Rare: Prologue
What are rare diseases? Being unique isn’t easy and Rare Diseases due to their low prevalence have not been an exception. In a law passed by the United States Congress in 1983 called the Orphan Drug Act, Rare Diseases are defined as conditions affecting less than 200,000 people in the United States. In contrast, the […]
FDA Approval of Amivantamab-vmjw: Advancing Treatment for EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer
The recent approval by the Food and Drug Administration (FDA) of amivantamab-vmjw (Rybrevant, Janssen Biotech) marks a significant milestone in the treatment landscape for non-small cell lung cancer (NSCLC). This approval targets locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, a subgroup historically challenging to treat effectively. The […]
Versatile “Zepbound” by Eli Lilly Became the First Weight Loss Drug Approved by the FDA
Food and Drug Administration (FDA) approved ZepboundTM (Tirzepatide) for weight management in 2023. This twincertin compound is approved for controlling blood sugar in patients suffering from T2DM. Trizepatide is a precise amalgamation of the glucose-dependent insulinotropic polypeptide (GIP) and Glucagon-like peptide (GLP-1) receptors and has added advantage over Semaglutide, Liraglutide, Dulaglutide (agonist or activators of […]
EpCAM CAR-T Therapy receives Dual IND from U.S. FDA and China CDE
Immunofoco, has achieved a significant milestone with the approval of Investigational New Drug (IND) applications by both the U.S. Food and Drug Administration (FDA) and the China Center for Drug Evaluation (CDE) for IMC001, an autologous CAR-T cell therapy targeting EpCAM. This groundbreaking approval marks a pivotal moment in the treatment landscape for advanced solid […]
STEMPeers’ Oncology digital news aggregator platform Onco-This-Week acquired by Rosenblatt Life Science Consultants
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February 9, 2024: Erie, PA: US-based non-profit, PhD Career Support Group DBA STEMPeers, a 21,000+ member organization, announces the asset purchase agreement of their oncology news aggregator platform, Onco-This-Week, to Rosenblatt Life Science Consultants (RLS Consultants). Rosenblatt Life Science Consultants is a global consulting and training firm focusing exclusively on the healthcare and life sciences […]
LAVA Therapeutics Announces Collaboration with Merck to Evaluate LAVA-1207 in Combination with KEYTRUDA
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“We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®,” said Stephen Hurly, President and Chief Executive Officer, LAVA. “To date, LAVA-1207 has demonstrated a favorable safety profile and shown preliminary signs of […]
Inhibrx Announces Sale of INBRX-101 to Sanofi for an aggregate value of up to $2.2B
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“Inhibrx and Sanofi announced that the companies have entered into a definitive agreement under which Aventis Inc., a Pennsylvania corporation (a subsidiary of Sanofi) will acquire all the assets and liabilities associated with INBRX-101, an optimized, recombinant alpha-1 antitrypsin (“AAT”) augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin […]
2023 Year-End Annamycin Clinical Trials Preliminary Data and 2024 Expectations for Multiple Data Readouts and Transition to Pivotal Phase 2B/3 announced
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“Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs. We are well-positioned to continue building upon our encouraging growing body of preliminary clinical data and transition to pivotal Phase 2B/3 clinical trials by year-end 2024. We believe that Annamycin should be positioned […]
FAILED TRIAL: Phase 3 EVOKE-01 study did not meet its primary endpoint of OS in previously treated metastatic NSCLC
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“The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective […]
Submission of a Rolling NDA to the FDA for UGN-102 initiated
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“The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen. “We look forward to working closely with the FDA throughout […]
Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed R/R Multiple Myeloma
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“This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, M.D., senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “We look […]
UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers
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“The strategic alliance with medac fortifies our commitment to continuously innovate novel, non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen. “The 80 mg formulation of mitomycin from medac is specifically designed to be mixed with our RTGel® technology, which may provide advantages for patients looking for […]
First Patient Treated in the Phase 2a Trial of LSTA1 in Patients with Glioblastoma Multiforme
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“We are very pleased to announce the first patient treated in this Phase 2a study evaluating LSTA1 in patients with newly diagnosed GBM, a very aggressive brain tumor that is often fatal. We hold great hopes for the benefits of LSTA1 in this indication based on preclinical evidence that demonstrates LSTA1 enhances penetration through the […]
IK-595 first cohort treated and cleared safety evaluation window
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“We are laser focused on driving IK-930 and IK-595 forward in the next year to interpretable and clear data reads as we continue to build value for investors,” commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. “Our extended team has achieved many significant milestones together, and IK-930 and IK-595’s clinical progress is evidence of […]
Imfinzi plus transarterial chemoembolisation (TACE) and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolisation
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Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Medicine at Clínica Universidad de Navarra, Pamplona, Spain and a lead investigator in the EMERALD-1 trial, said: “In this earlier liver cancer setting, embolisation alone has been the standard of care for more than 20 years, and rates of disease progression have remained […]
Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant NSCLC
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“Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC,” said Dan Paterson, President […]
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
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Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Securing orphan drug designation for a product candidate incorporating a novel molecular entity, not yet approved by any regulatory agency, underscores our unwavering commitment to advancing the frontiers of scientific discovery within the repurposing space.”
European Commission approves Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
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“We are pleased to introduce the first subcutaneous PD-L1 cancer immunotherapy in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.”
Boehringer Ingelheim and 3T Biosciences signed a second T-cell focused collaboration
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“At Boehringer Ingelheim, we are committed to transforming patients’ lives. The initial success of our work with 3T gives us confidence that together we can and will expand and accelerate our pipeline of first-in-class T-cell based anti-cancer therapies,” said Lamine Mbow, Ph.D., Global Head of Cancer Immunology and Immune Modulation, Boehringer Ingelheim.
AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies
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“As we continue to strengthen our oncology portfolio, we believe that in-situ CAR-T cell therapy represents a paradigm shift utilizing genetic medicine concepts,” said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research at AbbVie. “We look forward to working with Umoja’s team to advance next-generation in-situ CAR-T therapies, and potentially expand the […]
Last Patient Enrolled in Phase 3 TRIDENT Trial in Newly Diagnosed Glioblastoma
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“TTFields therapy has played a critical role in the treatment of newly diagnosed glioblastoma for nearly a decade, and the TRIDENT trial represents the potential evolution of this treatment paradigm by introducing TTFields earlier, at the same time as radiation therapy and temozolomide,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Preclinical research has shown that […]
Enrollment opens for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
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Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, “While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence […]
Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer Provided
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“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of […]
TIVDAK® sBLA Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
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“The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting TIVDAK as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” said Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer. “The FDA acceptance of […]
Update on Zolbetuximab Biologics License Application in U.S.: FDA rejects the application
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Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas said, “We remain confident in zolbetuximab’s clinical profile and potential to fill a significant therapeutic gap for those diagnosed with advanced gastric or GEJ cancer whose tumors are CLDN18.2 positive. Astellas is committed to working with the FDA and the third-party manufacturer […]
FDA Approves KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer
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“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and […]