Precision in NSCLC Treatment: The Predictive Power of TROP2-QCS in Datopotamab Deruxtecan Therapy
Introduction The quest for more personalized and precise cancer treatments has gained momentum with the recent findings from the TROPION-Lung01 Phase III trial. This pivotal study explores the role of the TROP2-QCS biomarker in predicting clinical outcomes for patients with non-small cell lung cancer (NSCLC) undergoing treatment with datopotamab deruxtecan (Dato-DXd). The trial highlights a […]
FDA Approves Lazertinib and Amivantamab-vmjw Combination for First-Line Treatment of EGFR-Mutant NSCLC
Introduction The U.S. Food and Drug Administration (FDA) has granted approval for the combination of lazertinib (Lazcluze) and amivantamab-vmjw (Rybrevant) as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific epidermal growth factor receptor (EGFR) mutations. This approval marks a significant advancement in the treatment landscape for […]
FDA Approves Neoadjuvant/Adjuvant Durvalumab for Resectable NSCLC
Introduction The U.S. Food and Drug Administration (FDA) recently approved the use of durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment for adults with resectable non-small cell lung cancer (NSCLC). This treatment regimen is followed by durvalumab monotherapy as adjuvant therapy post-surgery. This approval is specifically for patients with tumors measuring […]
FDA Grants Accelerated Approval to Afamitresgene Autoleucel for Unresectable or Metastatic Synovial Sarcoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a genetically modified autologous T cell immunotherapy. This approval targets adult patients with unresectable or metastatic synovial sarcoma, particularly those who have undergone prior chemotherapy and possess specific HLA-A alleles, with tumors expressing the melanoma-associated antigen A4 (MAGE-A4). […]
FDA Expands Endometrial Cancer Indication for Dostarlimab-gxly with Chemotherapy
The Food and Drug Administration (FDA) has approved a new treatment regimen for adult patients with primary advanced or recurrent endometrial cancer (EC). This approval includes the combination of dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly. This regimen was previously approved for patients with mismatch repair deficient (dMMR) or microsatellite instability-high […]
FDA Approves Daratumumab and Hyaluronidase-fihj Combination for Multiple Myeloma
The Food and Drug Administration (FDA) has approved the combination of daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) with bortezomib, lenalidomide, and dexamethasone for the induction and consolidation treatment of newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant (ASCT). Image Source: Vinoth Khandelwal This approval was based on the results of the PERSEUS […]
Merck Signs MoU with Gene Therapy Research Institution to Advance Gene Therapy Production
Merck, a prominent science and technology company, has recently signed a non-binding Memorandum of Understanding (MoU) with Gene Therapy Research Institution Co., Ltd. (GTRI), a Japanese clinical-stage biotech start-up focused on developing gene therapies using adeno-associated virus (AAV) vectors. This collaboration marks one of the first clinical-stage applications of Merck’s Sf-RVN® Insect Cell Line for […]
FDA Grants Accelerated Approval to Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to epcoritamab-bysp (Epkinly), developed by Genmab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This approval marks a significant advancement in the treatment options for FL, a type of non-Hodgkin lymphoma. […]
FDA Grants Accelerated Approval to Adagrasib with Cetuximab for KRAS G12C-Mutated Colorectal Cancer
The Food and Drug Administration (FDA) has granted accelerated approval for the combination of adagrasib (Krazati; Mirati Therapeutics, Inc.) and cetuximab for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). This approval applies to patients who have previously been treated with chemotherapy regimens based on fluoropyrimidine, oxaliplatin, and irinotecan, […]
FDA Approves Blinatumomab as Consolidation Therapy for CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia
The Food and Drug Administration (FDA) has granted approval for blinatumomab (Blincyto, Amgen) for use in adult and pediatric patients aged one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) during the consolidation phase of multiphase chemotherapy. This decision marks a significant advancement in the treatment regimen for […]
FDA Grants Accelerated Approval to Repotrectinib for NTRK Fusion-Positive Tumors
The Food and Drug Administration (FDA) has granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb; BMS) for the treatment of adult and pediatric patients aged 12 and older with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This approval covers patients with locally advanced or metastatic tumors for whom surgical resection would […]
US FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has approved lisocabtagene maraleucel (Breyanzi), developed by Juno Therapeutics, Inc., for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). This approval marks a significant advancement […]
Follicular Lymphoma Treatment Option Gains FDA Approval: Lisocabtagene Maraleucel
The Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics). Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapies are a type of immunotherapy that involves engineering a patient’s T cells to recognize and attack cancer cells. Lisocabtagene maraleucel T cells are specifically designed to target […]
FDA Grants Accelerated Approval to Tarlatamab-dlle for ES-SCLC
The Food and Drug Administration (FDA) has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for the treatment of extensive stage small cell lung cancer (ES-SCLC) in patients with disease progression following platinum-based chemotherapy. Tarlatamab-dlle is an innovative bi-specific T-cell engager designed to direct the body’s immune response specifically towards cancer cells. This mechanism allows […]
Sanofi & Novavax Partner on COVID-19 and Flu Combination Vaccines
Sanofi and Novavax, two leading companies in the field of vaccine development, have recently announced a significant co-exclusive licensing agreement aimed at broadening access to COVID-19 vaccines and exploring novel combination vaccines targeting both COVID-19 and influenza. This collaboration underscores the companies’ commitment to advancing public health by leveraging their respective strengths in vaccine research, […]
Accelerated Approval of Tovorafenib for Pediatric Low-Grade Glioma: A Breakthrough in BRAF-Altered Therapy
Pediatric low-grade glioma (LGG) with BRAF alterations presents a significant therapeutic challenge, lacking approved systemic treatments. However, a recent milestone has been achieved with the Food and Drug Administration’s (FDA) accelerated approval of tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients aged 6 months and older with relapsed or refractory pediatric LGG harboring BRAF fusions, […]
The US FDA approves lutetium Lu 177 dotatate for pediatric patients with GEP-NETS
The Food and Drug Administration has recently approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients aged 12 and above diagnosed with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which include foregut, midgut, and hindgut neuroendocrine tumors. This approval, granted in 2018 for adults, marks the first […]
FDA Approval of Nogapendekin Alfa inbakicept-pmln: A Breakthrough in Bladder Cancer Treatment
Bladder cancer presents a significant healthcare challenge, particularly non-muscle invasive bladder cancer (NMIBC), which can be challenging to treat effectively. The recent approval of nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) by the Food and Drug Administration (FDA) offers a promising new option for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with […]
Advancing Alzheimer’s Disease Diagnosis
Roche recently announced a significant milestone in Alzheimer’s disease diagnosis with the FDA granting Breakthrough Device Designation to its Elecsys pTau217 assay. Developed in collaboration with Eli Lilly, this blood test aims to identify amyloid pathology, a crucial marker for Alzheimer’s disease. The Elecsys pTau217 assay promises a faster and more accurate diagnosis of Alzheimer’s […]
Accelerated Approval Granted to Enhertu for HER2-Positive Solid Tumors
The Food and Drug Administration (FDA) has recently granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu). This approval is significant for adult patients suffering from unresectable or metastatic HER2-positive (IHC3+) solid tumors who have exhausted prior systemic treatment options. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly […]
Advancing Cancer Treatment: FDA Approval of Mirvetuximab Soravtansine-Gynx for Platinum-Resistant Epithelial Ovarian Cancer
Image Source: Vinoth Khandelwal In a recent development for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, the Food and Drug Administration (FDA) has recently approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]). This approval marks a milestone in addressing the medical needs of adult patients with FRα […]
Takeda’s ICLUSIG Receives FDA Approval for Frontline Treatment of Ph+ Acute Lymphoblastic Leukemia
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 […]
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 […]
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 […]
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 […]
