FDA News

Based on durable response data, TAR-200 has been given priority review for the treatment of patients with high-risk non–muscle-invasive bladder cancer.

The selective internal radiation therapy SIR-Spheres has been approved by the FDA for use in patients with unresectable hepatocellular carcinoma.

Sunvozertinib has received accelerated approval for use in advanced or metastatic non–small lung cancer harboring EGFR exon 20 insertion mutations.

The FDA has given accelerated approval to the BiTE, linvoseltamab, for use in the fifth line of therapy for relapsed/refractory multiple myeloma.

Oncologic therapies approved in June included indications in genitourinary, lung, hematologic, and head and neck cancers.

The FDA removed REMS and reduced certain monitoring needs for liso-cel and ide-cel in B-cell malignancies.

Illuccix, a preparation kit for injectable Ga-68, has been approved to select patients for radioligand therapy before taxane chemotherapy.

Dato-DXd was granted accelerated approval for use in adults with EGFR-mutated NSCLC after EGFR-targeted therapy and platinum-based chemotherapy.

Per ODAC and CHMP recommendations, subcutaneous daratumumab may become the first approved treatment for smoldering myeloma. Here’s what nurses should know.

The FDA approved a perioperative pembrolizumab regimen in head and neck squamous cell carcinoma, marking the first approval in this cancer type in 6 years.

An oral tablet formulation of zanubrutinib was approved for use in patients with certain lymphomas or leukemia and Waldenström macroglobulinemia.

UGN-102 has received FDA approval for use in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer.

The tyrosine kinase inhibitor taletrectinib has been approved for use in patients with ROS1-positive non-small cell lung cancer.

The FDA approved the first oral treatments for paraganglioma, pheochromocytoma, and anal cancer in May.

The FDA approved darolutamide monotherapy for use in metastatic hormone-sensitive prostate cancer following ARANOTE findings.

The novel antibody-drug conjugate EBC-129 has been fast tracked by the FDA for approval in pancreatic ductal adenocarcinoma.

The oral TKI sevabertinib has been granted priority review for use in patients harboring HER2 mutations in non-small cell lung cancer.

Retifanlimab has received approval for the frontline treatment of advanced anal cancer from the FDA.

Telisotuzumab vedotin-tllv has earned accelerated approval for use in patients with non-squamous non-small cell lung cancer with high c-Met overexpression.

Belzutifan has become the first FDA-approved oral therapy for pheochromocytoma or paraganglioma.

ADRX-0706 has received FDA fast track designation for the treatment of metastatic or locally advanced squamous cell cervical cancer.

The safety and efficacy of givinostat is being assessed vs hydroxyurea in the phase 3 GIV-IN PV trial.

The FDA has granted accelerated approval to avutometinib and defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer.

The FDA granted a complete response letter with no safety concerns for the new drug application for TLX101-CDx’s use in glioma imaging.

Approvals in oncology during April included treatments for breast cancer, colorectal cancer, and more.

The selective CDK2 inhibitor INX-315 has been given FDA fast track designation for use in CCNE1-amplified, platinum-resistant ovarian cancer.

A ready-to-dilute formulation of thiotepa has been approved by the FDA for use in breast and ovarian cancers.

The FDA approved penpulimab-kcqx combination and monotherapy for non-keratinizing nasopharyngeal carcinoma.