FDA News

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.

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

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.

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.