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 […]
