FDA News

BCMA-targeting ADC belantamab mafodotin was approved for use in patients with relapsed/refractory multiple myeloma after 2 or more lines of treatment.

Following imlunestrant’s approval, Komal Jhaveri, MD, FACP, compares the oral SERD to its counterpart, elacestrant, in terms of composition and trials.

The FDA has granted approval to adjuvant cemiplimab treatment for patients with high-risk cutaneous squamous cell carcinoma after surgery and radiation.

The FDA has approved lurbinectedin plus atezolizumab for the treatment of extensive-stage small cell lung cancer following induction therapy with atezolizumab.

The REMS program for vandetanib in the treatment of patients with medullary thyroid cancer has been removed by the FDA.

The FDA has approved imlunestrant for the treatment of patients with ESR1-mutated ER+, HER2- metastatic breast cancer.

Subcutaneous pembrolizumab has been approved across all indications, cutting chair and administration times with a median injection time of 2 minutes.

When treating patients with bladder cancer using gemcitabine intravesical system, regular AE monitoring is necessary, said Gary Steinberg, MD.

Relacorilant’s new drug application for platinum-resistant ovarian cancer has been accepted by the FDA.

FDA accelerated approval was given to zongertinib for the treatment of patients with unresectable/metastatic nonsquamous NSCLC with HER2 TKD activating mutations.

The FDA has granted accelerated approval to dordaviprone for use in adult and pediatric patients with H3 K27M-mutated diffuse midline glioma.

A generic version of ibrutinib was granted tentative approval by the FDA for use in CLL and SLL with 17p deletion and Waldenström macroglobulinemia.

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 has approved tafasitamab in combination with lenalidomide and rituximab for adults with relapsed/refractory follicular lymphoma.

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.