FDA News

The FDA granted SIGX1094 fast track status as a treatment option for diffuse gastric cancer.

AUTX-703, a novel, oral KAT2A/B degrader, has received fast track designation for use in relapsed/refractory AML.

The FDA has given RZ-001 fast track designation for HCC after demonstrating therapeutic activity in preclinical studies.

Amezalpat has been granted FDA fast track designation as treatment for patients with hepatocellular carcinoma.

Findings from the ECHELON-3 trial supported the approval of brentuximab vedotin plus lenalidomide and rituximab for relapsed/refractory LBCL.

Serial CTRS, an AI-powered tool, has been granted FDA breakthrough device designation for classifying patients with NSCLC.

The FDA has granted breakthrough device designation to the ACR-368 OncoSignature assay for use in endometrial cancer.

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA.

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

T-DXd has received FDA approval for the treatment of unresectable or metastatic HR+, HER2-low/-ultralow breast cancer in patients whose disease progressed on prior endocrine therapy in the metastatic setting.

Treosulfan plus fludarabine was approved by the FDA for children and adults with AML or MDS before allogenic hematopoietic stem cell transplantation.

Datopotamab deruxtecan-dlnk received approval from the FDA for previously treated unresectable or metastatic, HR-positive, HER2-negative breast cancer.

The FDA has approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) whose disease progressed after chemotherapy.

The FDA approved acalabrutinib in combination with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous stem cell transplant.

GSK5764227 has been granted FDA breakthrough therapy designation, potentially expediting its development as a treatment for relapsed/refractory osteosarcoma.

The FDA has released draft guidance with recommendations on tissue biopsies in clinical trials for adults and children.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