FDA News

The FDA has released draft guidance with recommendations on tissue biopsies in clinical trials for adults and children.

Sunvozertinib received FDA priority review for advanced EGFR exon 20 insertion-positive non-small cell lung cancer progressing after chemotherapy.

Phase 1 data indicate invikafusp alfa's potential as a precision cancer immunotherapeutic in solid tumors that have progressed after PD-(L)1 therapy.

A new drug application has been submitted to the FDA for dordaviprone to treat recurrent H3K27M-mutant diffuse glioma.

A combination of avutometinib and defactinib has been granted priority review by the FDA for the treatment of KRAS-mutant recurrent low-grade serous ovarian cancer.

Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) was approved by the FDA for subcutaneous injection across approved solid tumor indications for nivolumab (Opdivo).

The FDA approved tislelizumab plus chemotherapy for the first-line treatment of unresectable or metastatic gastric or GEJ adenocarcinoma.

The FDA has granted approval for the use of encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer harboring a BRAF V600E mutation.

FDA gives nod of approval to first derived mesenchymal stromal cell therapy for the treatment of pediatric patients with steroid-refractory acute GVHD.

Ensartinib has received FDA approval for the first-line treatment of ALK-positive locally advanced or metastatic non–small cell lung cancer.

An FDA approval was granted for cosibelimab-ipdl for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma.

The FDA approved an oral solution of imatinib for multiple different cancer types.

The FDA accepted a supplemental new drug application to darolutamide plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.

The FDA approved an updated drug label for fludarabine phosphate for the treatment of B-cell chronic lymphocytic leukemia.

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 an accelerated approval to asciminib for newly diagnosed Ph+ chronic myeloid leukemia in the chronic phase.

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.