EP. 1: FDA Clears IND of OBI-902, Trop-2 ADC for Advanced Solid Tumors
Following clearance from the FDA, a phase 1/2 study will assess OBI-902 in Trop-2-overexpressing solid tumors, with plans for enrollment to begin later this year.
EP. 2: FDA Fast-Tracks INX-315 in Ovarian Cancer
INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.
EP. 3: FDA Issues CRL to TLX101-CDx, a Novel PET Imaging Agent for Glioma
The FDA requires more data to approve the application of TLX101-CDx for the detection and differentiation of glioma.
EP. 4: FDA Grants ISB 2001 Fast Track Designation in RRMM
Following promising phase 1 data, ISB 2001 has gained fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma.
EP. 5: FDA Issues Refusal to File for Nogapendekin Alfa Plus BCG in Papillary NMIBC
The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior positive feedback.
EP. 6: FDA Clears LP-184 IND for TNBC Trial as Monotherapy & PARP Inhibitor Combo
A phase 1b/2 trial in triple-negative breast cancer will assess LP-184 alone and with a PARP inhibitor in advanced cases.
EP. 7: FDA Lifts Clinical Hold on Tab-Cel Application in EBV+ PTLD
With the clinical hold on the tab-cel application lifted, phase 2 and 3 trials of the T-cell immunotherapy in patients with PTLD may resume.
EP. 8: FDA Accepts Narsoplimab BLA Resubmission for Transplant-Associated TMA
The resubmitted biologics license application for narsoplimab in transplant-associated thrombotic microangiopathy has been accepted by the FDA.
EP. 9: FDA Fast-Tracks Givinostat for Polycythemia Vera Treatment
The FDA granted fast track status to givinostat for treating high-risk polycythemia vera, supporting its potential shown in the ongoing phase 3 GIV-IN PV trial.
EP. 10: Avutometinib Plus Defactinib Gains FDA Approval in KRAS+ Ovarian Cancer
Avutometinib given with defactinib is now approved for the treatment of adult patients with recurrent low-grade serous, KRAS-positive ovarian cancer.
EP. 11: FDA Fast-Tracks Novel ADC in Cervical Cancer
ADRX-0706, a Nectin-4-targeted antibody-drug conjugate, has earned FDA fast track designation in advanced cervical cancer.
EP. 12: FDA Clears IND for Novel DLL3-Targeted ADC in Solid Tumors
The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug conjugate for solid tumors.
EP. 13: THE001, Novel Sarcoma Treatment, Earns FDA Orphan Drug Designation
THE001, a thermosensitive doxorubicin liposome for soft tissue sarcomas, received FDA orphan drug designation, offering development benefits.
EP. 14: FDA Approves Belzutifan in Advanced Pheochromocytoma and Paraganglioma
The FDA approved belzutifan as the first oral therapy for advanced or metastatic pheochromocytoma and paraganglioma in patients 12 years and older.
EP. 15: FDA Grants Telisotuzumab Vedotin Accelerated Approval in c-MET+ NSCLC
The FDA granted accelerated approval to telisotuzumab vedotin for the treatment of NSCLC with high c-MET protein overexpression.
EP. 16: FDA Approves Retifanlimab, First Frontline Treatment for Advanced SCAC
With significant survival improvements seen, the FDA has granted approval to retifanlimab for the first-line treatment of advanced anal cancer.
EP. 17: Novel CAR T Earns FDA RMAT Designation for Incurable Pediatric Brain Tumor
BCB-276 has earned regenerative medicine advanced therapy designation from the FDA in diffuse intrinsic pontine glioma, an incurable pediatric tumor.
