FDA News

The FDA granted an accelerated approval to zanidatamab-hrii for previously treated, unresectable or metastatic HER2-positve biliary tract cancer.

The FDA granted a fast track designation to ALE-P02 for patients with CLDN1-positive squamous solid tumors.

The FDA approved ninlotinib tablets that do not have mealtime restrictions for Ph-positive CML in chronic phase and CML that was previously treated.

The FDA granted elraglusib a rare pediatric disease designation for Ewing sarcoma based on findings from the 1/2 Actuate-1902 trial.

The FDA received a biologics license application for datopotamab deruxtecan for previously treated EGFR-mutant non-small cell lung cancer.

The FDA granted an orphan drug designation to herpes simplex virus type 1 (HSV-1) oncolytic virus MB-108 for malignant glioma treatment.

The FDA approved obecabtagene autoleucel (obe-cel; Aucatzyl) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The FDA extended the Prescription Drug User Fee Act date for the biologics license application seeking approval of zenocutuzumab for NRG1-positive lung and pancreatic cancer.

The FDA expanded the approval of methotrexate to include patients with pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.

The FDA granted a fast track designation to HC-7366 for adults with relapsed or refractory acute myeloid leukemia.

The PDUFA dates have been pushed for sotorasib and obeticholic acid for metastatic colorectal cancer and primary biliary cholangitis, respectively.

The FDA accepted a resubmission of a new drug application for frontline rivoceranib plus camrelizumab to treat unresectable, metastatic HCC.

The FDA approved neoadjuvant nivolumab plus chemo, followed by adjuvant nivolumab for non-small cell lung cancer without EGFR mutations or ALK rearrangements.

ODAC voted against the use of PD-L1 expression as a predictive biomarker in gastric cancers.

The agency approved selpercatinib for the treatment of patients with advanced or metastatic, RET-mutant medullary thyroid cancer.

The FDA approved osimertinib for locally advanced, unresectable stage III EGFR-mutated non-small cell lung cancer.

The FDA approved isatuximab plus bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed myeloma who are ineligible for ASCT.

The FDA approved amivantamab-vmjw plus chemotherapy for locally advanced or metastatic non–small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI.

The FDA approved pembrolizumab plus pemetrexted and platinum chemotherapy for advanced or metastatic malignant pleural mesothelioma.

The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.

The agency approved the subcutaneous injection of atezolizumab and hyaluronidase-tqjs for all of the adult indications as the intravenous formulation of atezolizumab.

Companion diagnostics have been approved by the FDA for olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer.

The FDA approved Boruzu, a new presentation of bortezomib, for subcutaneous or intravenous administration in patients with multiple myeloma and mantle cell lymphoma.

Throughout August, the FDA approved drugs for the treatment of diseases including non-small cell lung cancer, cutaneous T-cell lymphoma, astrocytoma/oligodendroglioma, and endometrial cancer.

Breakthrough therapy designation has been granted by the FDA to GSK5764227 for potential use in some patients with extensive-stage SCLC.

A supplemental biologics license application has been accepted by the FDA for nivolumab plus ipilimumab as first-line treatment for unresectable hepatocellular carcinoma.

Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.

A CRL has been issued by the FDA to the biologics license application seeking approval of linvoseltamab to treat some patients with multiple myeloma.